JP2010158531A - Catheter apparatus and system having the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a catheter apparatus which can exchange heat by using a body fluid on site for modifying a temperature at a target region in a body, and a system including the catheter apparatus. <P>SOLUTION: The catheter apparatus 420 comprises a spindly flexible catheter, at least one fluid lumen, a heat exchange instrument 440 located on the catheter, and a body fluid-inducing sleeve 422 formed around a segment of the catheter. The catheter apparatus can modify the temperature at the target region in the body by using the body fluid on site. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention generally relates to selectively changing and adjusting a patient's body temperature and controlling the temperature of a fluid delivered to a specific target site within a body structure. Specifically, the present invention relates to a method for treating or inducing hypothermia or hyperthermia by inserting a catheter into a patient's blood vessel and selectively transferring heat from or to the blood flowing in the blood vessel. And devices and methods and devices for changing the temperature of the fluid delivered to a target location while the fluid is in the patient.

  The invention further relates to selectively altering and adjusting the temperature of the whole body and the temperature of selected target sites in the body, including the brain. Specifically, the present invention reduces the temperature of the brain by the heat transfer portion of the heat transfer catheter and is in contact with or circulating in the region of the brain that provides local hypothermia and temperature regulation. It relates to a method and an apparatus for cooling a fluid that is circulating around or in the same region.

  The following patent application is a continuation-in-part of Application No. 08 / 584,013 filed on January 11, 1996 and Application No. 08 / 769,931 filed on December 19, 1996. . No. 08 / 584,013 is a continuation application of previously abandoned application No. 08 / 015,774 filed on Feb. 10, 1993, and as US Pat. No. 5,486,208, January 1996. This is a continuation-in-part of application No. 08 / 324,853, filed on Oct. 23, filed Oct. 18, 1994. All of the above documents are incorporated herein by reference.

  Under normal circumstances, the human body temperature regulation system maintains a constant temperature of about 37 ° C. (98.6 ° F.). The heat loss to the environment is precisely balanced by the internal heat produced in the body.

  Hypothermia is a condition in which body temperature is abnormally low, generally characterized by a core temperature of 35 ° C. or less, and hypothermia can be further clinically defined by its severity. For example, it is described as mild hypothermia in the body temperature range of 32 ° C to 35 ° C, moderate hypothermia in the range of 30 ° C to 32 ° C, and severe hypothermia in the range of 24 ° C to 30 ° C. And body temperatures below 24 ° C. may constitute hyperthermia. While the above ranges may provide a valid basis for discussion, they are not absolute and the definitions vary greatly as shown in medical articles.

  Hyperthermia is defined as a condition in which body temperature is abnormally high, and hyperthermia can occur as a result of exposure to a hot environment or surroundings, too much fluency, or fever. Body core temperatures range from 38 ° C. to 41 ° C. depending on symptoms such as heat, and can be much higher when exposed and overly refined. Like hypothermia, hyperthermia is a dangerous condition that can be fatal.

  Both hypothermia and hyperthermia are harmful and may require treatment, but in some cases, hyperthermia or hypothermia, especially hypothermia, is therapeutically or otherwise. There are advantages, and therefore may be intentionally triggered. For example, the brain may be damaged or other nerves may be damaged due to the hardening of myocardial infarction or the duration of cardiac arrest during cardiac surgery. Hypothermia is recognized in the medical community as an acceptable neuroprotective measure during cardiovascular surgery, and patients are therefore often maintained in a state that induced hypothermia during cardiovascular surgery. In addition, hypothermia can be induced as a neuroprotective measure during brain surgery. Does hypothermia interrupt blood flow to the brain or spinal cord, for example, head injury, spinal cord injury, stroke (sometimes called stroke), spinal surgery, or treatment of aneurysms? Other situations may be beneficial for patients undergoing surgery that can be compromised or other types of surgery where neuroprotection is desirable.

  Nerve tissue, that is, all tissues of the nervous system, including the brain and spinal cord, have ischemic or hemorrhagic heart disease, blood deficiency for any reason including cardiac arrest, intracerebral hemorrhage, and head trauma Particularly vulnerable to vascular disease processes including but not limited to. In each of these cases, damage to brain tissue can be caused by ischemia, pressure, edema, or other processes, which can result in loss of brain function and permanent neurological deficits. Lowering brain temperature slows down post-injury neurotransmitters such as glutamate, reduces brain metabolic rate, decreases intracellular calcium, prevents intracellular protein synthesis inhibition, and reduces free radical formation Of course, it provides neuroprotection by several mechanisms, including other enzyme cascades, even genetic responses. Such deliberately induced hypothermia may prevent some of the damage to the brain and other neurological tissues during surgery, or as a result of stroke, intracerebral hemorrhage, and trauma May prevent some of the damage to the brain and other neurological tissues.

  Particularly in the treatment of stroke, intentionally induced hypothermia can be used therapeutically. A stroke (sometimes referred to as a stroke) is a severely debilitating complex caused by blockage (ischemic stroke) or rupture (hemorrhagic stroke) of blood vessels within or into a specific brain region Is a serious disease. During a stroke, brain cells are damaged by hypoxia or by increased pressure. Such a phenomenon can ultimately lead to death or necrosis of brain tissue. In general, at least one goal in an intervention for the treatment of stroke is to maintain as much brain tissue function as possible. However, current treatment for stroke is essentially primarily supportive. New therapies such as clot lysing drugs are available, but they may only be suitable for the treatment of ischemic stroke, and to avoid side effects related to intracerebral hemorrhage General use within time). In fact, it is difficult to treat a stroke in this time domain because patients often do not arrive at a medical facility a few hours after the onset of stroke. As a result, most strokes are not actively treated with medical treatment. Treatments that extend the time domain and treatments that protect brain cells from death can have a significant impact on patient care.

  Experimental studies on ischemia have shown that treatment of hypothermia during or shortly after a stroke or ischemic injury reduces the volume of infarcted brain tissue in the animal. Therefore, it is believed that applying hypothermia to patients suffering from stroke or who have recently suffered may be effective.

  Despite the acceptance of hypothermia as a neuroprotective measure, hypothermia is not widely used except in a surgical setting. Also, most current practices are intended to provide hypothermia to the brain by inducing systemic hypothermia with systemic treatment. However, generalized hypothermia presents many difficulties and is cumbersome to perform on patients who are not under general anesthesia. Lowering the patient's whole body temperature not only takes a considerable amount of time, but also includes discomfort problems such as cardiac arrhythmias, blood clotting problems, increased prevalence of infection, and significant tremors The patient is affected by hypothermia, which is harmful to the body and mind.

  For example, adjustment of body temperature to maintain normal body temperature (usually 37 ° C.) is often preferred. For example, in a patient under general anesthesia, the mechanism that regulates the body's normal body temperature may not be fully functional, and an anesthesiologist may need to artificially adjust the patient's body temperature. Similarly, a patient may lose a large amount of heat to the environment, for example during a major surgery, and generate enough heat to compensate for the loss of heat in the unassisted patient's body May not be possible. Devices and methods for regulating body temperature, for example, by applying heat for maintaining normal body temperature are desirable.

  In particular, in a surgical setting, blood or other fluid is sometimes heated or cooled outside the patient's body and then introduced into the body to heat or cool the body or target site within the body. However, heating or cooling fluid outside the patient's body is cumbersome and requires sophisticated equipment. For example, in surgery, a patient's temperature can be adjusted by a bypass machine, which removes a large amount of patient blood outside the body, heats or cools it, and reintroduces it into the patient's bloodstream. One particular application of this procedure is systemic hypothermia, often induced during cardiac surgery. Other examples include hypothermia induced during neurosurgery and aortic or other vascular surgery.

  The use of external procedures to induce hypothermia, such as a bypass machine, is a very invasive procedure that pumps large amounts of patient blood over time. Pumping blood out is harmful to the blood and it is usually avoided to pump blood into the patient for a long period of time (eg longer than 1 or 2 hours). In addition, such treatment may be required for systemic therapy of patients, such as preventing blood clotting, which may have other adverse consequences in stroke patients due to heparin, for example.

  Means have been proposed for applying heat to or removing heat from a patient's blood that does not require external pumping. For example, U.S. Pat. No. 6,077,091 to Ginsburg describes a specific catheter structure developed for the treatment of patients suffering from hypothermia or hyperthermia. The entire disclosure of that patent is incorporated herein by reference. The patent was issued from one of the aforementioned applications from which this application claims priority. The catheter disclosed in that patent is inserted into a blood vessel and a portion of a heated or cooled catheter and affects the overall temperature of the patient by transferring heat to the patient's blood. Such devices and methods may avoid the problems associated with pumping blood in and out, but do not eliminate the problems that occur when the entire body becomes hypothermic.

  Attempts have been made to achieve local hypothermia in the brain, for example, attempts to place the head in a cooled helmet or cover, or even attempts to inject a cold solution locally in the head. is there. Attempts to cool the brain by directly cooling the head surface can be difficult if the central temperature of the brain is effectively reduced due to the isolating nature of the skull, or if the head surface is cooled, It has proved impractical or ineffective due to the fact that the blood flow may not be able to provide sufficient heat transfer to the brain itself. Patients, especially those who are not under general anesthesia, may find it difficult to withstand that the head is immersed in a cold solution or directly exposed, or that the head surface is cooled. Absent.

  An apparatus that facilitates heat transfer to or from the target location by internal heat addition or cooling is advantageous. It is well known in the art to transfer heat by direct contact with a specific tissue with a balloon catheter. For example, in U.S. Patent No. 6,057,071 to Spears, a heated balloon is used from the surface of the balloon during percutaneous transluminal coronary angioplasty (PTCA) to fuse the split tissue. It is described to apply heat directly to the dilated artery wall. However, this device was operated by direct contact between the vessel wall in question and the highly heated balloon surface.

  Also shown is a balloon that can function as an ongoing heat transfer balloon with a continuous flow of heat transfer medium passing through the balloon. For example, in U.S. Patent No. 6,057,031 to Saab, each of the concentric inflow and outflow lumens is transferred to maintain a continuous flow of heat transfer liquid in the balloon for heat transfer control to adjacent tissue. Terminate in the thermal balloon.

  U.S. Patent No. 6,057,049 to Taheri discloses a balloon in which a heated fluid, such as a heated saline solution, is circulated through a pulsating balloon. As the heat transfer fluid flows through the balloon, heat from the fluid can be applied to the blood to treat the patient's hypothermia. The affected blood flow is not normally directed in a certain direction, and it is not disclosed that the temperature of the target site is altered by a Tahari heated balloon. Also shown is a form of balloon, such as a balloon used in PTCA, to provide a passage for blood to flow from the proximal side to the distal side of the balloon blocking the blood vessel. For example, such an auto-perfusion balloon angioplasty catheter is shown in US Pat. No. 6,057,097 to Sahota and is applied to Saab, which is discussed for use in angioplasty. The multi-lumen balloon shown in U.S. Pat. No. 6,057,034 shows a balloon vessel when the balloon is inflated to apply pressure for angioplasty to the vessel wall and other completely blocked vessel passages. A multi-lumen balloon catheter configured to perfuse blood from the proximal side to the distal side of the forming catheter is disclosed.

US Pat. No. 5,486,208 US Pat. No. 5,019,075 US Pat. No. 5,624,392 US Pat. No. 5,269,758 U.S. Pat. No. 4,581,017 US Pat. No. 5,342,301

  It would be desirable to devise a device that can heat or cool a liquid, such as blood, in the body and that can be directed to a target location after the liquid has been heated or cooled. It would be particularly advantageous if a device was devised that could use only the patient's own heart as a pump to guide the liquid to the desired location. It would also be advantageous if a method was devised to induce heated or cooled blood to a target site on the patient's body for a length sufficient to affect the temperature of the target site. .

  A method of treating a patient to protect tissue (particularly nerve tissue) by induction of hypothermia is desirable. The protection of the specific target tissue by inducing hypothermia in the specific target tissue by cooling the body fluid induced in the specific target tissue in situ is particularly advantageous.

  A system for controlling such a device in a simple and predictable manner is also desirable. It would be particularly desirable if such a system could control the device in conjunction with feedback data obtained from the patient to control the device that has a predictable and selective effect on the temperature of the patient's target site.

  In order to solve the above-mentioned object, the invention according to claim 1 is a catheter device that can be inserted into an anatomical structure of a mammalian patient, through which the body fluid passes through the target of the patient. The catheter device functions to perform in-situ heat exchange with body fluids to change the temperature of the target region, and the catheter device has a proximal end and a distal end. An elongate flexible catheter, the overall length of the flexible catheter being defined as the distance between its proximal and distal ends, and at least one fluid lumen through which the heat exchange fluid can circulate A heat exchanger disposed in a first position on the catheter, and the heat exchanger circulates through the body fluid flowing in the heat exchanger and in close proximity to the heat exchanger to exchange heat. To exchange heat with the fluid A body fluid guide sleeve formed around a segment of the catheter including the first position where at least a portion of the heat exchanger is disposed, and the first position extends shorter than the entire length of the catheter. The body fluid guiding sleeve forms a space through which the body fluid flows between the body fluid guiding sleeve and the catheter, and the body fluid guiding sleeve exchanges heat with the body fluid inlet disposed on the proximal side of the heat exchanger. A bodily fluid outlet arranged at the tip side of at least a part of the vessel, and the bodily fluid enters the flow space through the bodily fluid inlet and is in close proximity to exchange heat with at least a part of the heat exchanger And then exiting the bodily fluid outlet and leading to a passage in fluid communication with the target area of the patient's body. You .

  The invention of claim 2 is the catheter device of claim 1 for adjusting the temperature of the target area of the patient's body, wherein the body fluid passes through the first anatomical conduit having the first diameter. The first anatomical conduit is in fluid communication with a second anatomical conduit having a second diameter greater than the first diameter so that the fluid can be connected and fluid can flow back and forth. A body fluid outlet is disposed at the distal portion, a body fluid inlet is disposed at the proximal portion, and the distal portion is advanced through the first anatomical conduit while the proximal portion is first. The body fluid from the second anatomical conduit is sized to remain in place inside the anatomical conduit, and the body fluid from the second anatomical conduit enters the flow space through the body fluid inlet and exchanges heat with the heat exchanger. Flow in the flow space as close as possible, then from the body fluid outlet Te, it enters the first anatomical conduit and reach the target area of the patient's body, and its gist that.

  The invention described in claim 3 is the catheter device according to claim 2, wherein the diameter of the cross section of the distal end portion of the body fluid guiding sleeve is smaller than the diameter of the section of the proximal end portion of the body fluid guiding sleeve. To do.

  According to a fourth aspect of the present invention, in the catheter device according to the second aspect, the distal end portion has a shoulder portion formed in the distal end portion, and the shoulder portion forms a tight seal within the anatomical conduit. It is sized and shaped so that almost all flow of body fluid from the second anatomical conduit to the first anatomical conduit is allowed to flow through the body fluid guide sleeve. .

  According to a fifth aspect of the present invention, in the catheter device according to the first aspect, the heat exchanger includes at least one balloon through which the heat exchange fluid circulates, and the heat exchange fin includes a plurality of lobes. This is the gist.

  The invention according to claim 6 is characterized in that, in the catheter device according to claim 1, at least one heat exchange fin includes at least one outwardly extending longitudinal fin.

  The gist of the seventh aspect of the present invention is that, in the catheter device according to the first aspect, the at least one heat exchange fin includes at least one outwardly extending annular fin.

  The gist of the invention according to claim 8 is that, in the catheter device according to claim 1, at least one heat exchange fin comprises at least one outwardly extending helical fin.

The gist of the invention according to claim 9 is that, in the catheter device according to claim 1, at least one heat exchange fin includes a plurality of outwardly extending protrusions.
According to a tenth aspect of the present invention, in the catheter device according to the first aspect, the catheter further includes an insertion portion to be inserted into the patient's body and a working lumen, and the insertion portion extends from the distal end to a point shorter than the proximal end. The gist is that the working lumen extends through at least a portion of the insertion portion.

  The invention according to claim 11 provides a system including the catheter device according to claim 10, further combined with a guide wire sized to pass through the working lumen.

A twelfth aspect of the present invention provides a system including the catheter device according to the tenth aspect of the present invention, which is further combined with a device for injecting a drug into a working lumen.
According to a thirteenth aspect of the present invention, in the system of the twelfth aspect, the infusion device is a thrombolytic agent, an anticoagulant, a neuroprotective agent, a barbitur agent, an anti-seizure agent, an oxygenated perfusate, a vasodilator The gist is to contain a drug selected from the group consisting of: a vasospasm inhibitor, a platelet activation inhibitor, and a platelet adhesion inhibitor.

  A fourteenth aspect of the present invention provides a system including the catheter device according to the tenth aspect, which is further combined with a diagnostic probe capable of passing through a working lumen.

  The invention according to claim 15 is the system according to claim 14, wherein the diagnostic probe is selected from the group consisting of an angiographic catheter, a temperature sensor, a pressure sensor, a blood gas sensor, and an enzyme sensor. The gist.

  The invention according to claim 16 is a system including the catheter device according to claim 10, a device for injecting a contrast medium for X-ray imaging into the working lumen, and X injected into the working lumen. A system further combined with an imaging device for imaging a contrast agent for radiography.

The invention according to claim 17 provides a system including the catheter device according to claim 10, further combined with a treatment device capable of passing through a working lumen.
The invention according to claim 18 is the system according to claim 17, wherein the treatment device is an angioplasty catheter, an embolectomy catheter, an occlusion member delivery catheter, an embolus member delivery catheter, an electric acupuncture device, and a microcatheter. It is selected from the group of treatment devices consisting of:

  According to a nineteenth aspect of the present invention, in the catheter device according to the first aspect, a valve is provided at the body fluid inlet, and the valve is operable between an open state and a closed state. The gist of the invention is to prevent the flow of fluid through the body fluid inlet into the body fluid guide sleeve and, in the closed state, out of the body fluid guide sleeve through the body fluid inlet.

  According to a twentieth aspect of the present invention, in the catheter device according to the first aspect, the catheter has a distal shaft portion, and the distal shaft portion extends from the inside of the body fluid guiding sleeve on the distal side of the body fluid guiding sleeve, and the distal shaft portion Has a central lumen therethrough, the central lumen being in fluid communication with the flow space in a first position, in fluid communication with the passage, and in fluid communication with the target region in a second position. This is the gist.

  The gist of the invention according to claim 21 is that, in the catheter device according to claim 20, the body fluid guiding sleeve is sealed around the tip shaft on the tip side of the first position.

  The invention according to claim 22 is a catheter device disposed in a fluid-containing part of the body of a mammalian patient to perform in situ heat exchange, the catheter device comprising a proximal end and a distal end. An elongate flexible catheter, the total length of the flexible catheter is defined as the distance between its proximal end and the distal end, and the flexible catheter has an insertion portion to be inserted into the patient, the insertion portion from the distal end The heat exchanger extends to a point shorter than the proximal end, is located in the first position on the catheter, and the heat exchanger is in close proximity to the body fluid and the heat exchanger to be in heat exchange with the heat exchanger. Functioning to exchange heat with the heat exchange fluid circulating through it, the first position extends less than the total length of the catheter, the heat exchanger is curved and follows the outer diameter of its curvature. Has an outer surface and an inner diameter of its curvature Has an inner surface along, the outer and inner surfaces to provide a catheter device, comprising a have a substantially different thermal transmittance, a.

The gist of the invention described in claim 23 is that, in the catheter device according to claim 22, the upper surface has substantially higher heat transmittance than the lower surface.
According to a twenty-fourth aspect of the present invention, in the catheter device according to the twenty-third aspect, the aorta of a human patient is curved so that blood flowing to the head passes through the upper surface in close proximity to transfer heat. The gist is that it is formed in a size and shape that are arranged along.

  The invention according to claim 25 is a system that controls the temperature of a patient in a controllable manner, the system comprising an elongate flexible catheter having a proximal end and a distal end, and a heat exchanger. And the heat exchanger functions to exchange heat between the bodily fluid in close proximity to the heat exchanger and the heat exchange fluid that circulates through the heat exchanger. A plurality of sensors for sensing data from the patient, data from at least one of the sensors includes body temperature, and responding to data from at least one of the sensors to achieve and maintain a target body temperature In order to do so, a system is provided that includes a controller that receives signals from sensors and controls the operation of the catheter device.

  The gist of the invention described in claim 26 is that the system according to claim 25 further includes a heat exchange unit, and the heat exchange unit functions to exchange heat with the heat exchange fluid.

The gist of a twenty-seventh aspect of the present invention is that, in the system of the twenty-sixth aspect, the heat exchange unit comprises a solid thermoelectric cooler.
The invention according to claim 28 is the system according to claim 26, wherein the target parameter is temperature, the sensor is a temperature sensor, and the controller can function to operate the heat exchange unit. The gist.

  The gist of a twenty-ninth aspect of the present invention is that the system according to the twenty-fifth aspect further includes a plurality of catheter devices, and the control device can function to control each of the catheter devices.

  The invention according to claim 30 is the system according to claim 29, wherein at least one catheter device applies heat to the bodily fluid in a first position, and at least one catheter device heats from the bodily fluid in a second position. The gist is to take away.

  The invention of claim 31 is a system that controls the patient's temperature in a controllable manner, the system comprising an elongate flexible catheter each having a proximal end and a distal end, and a first position on the catheter. A plurality of catheter devices having a heat exchanger disposed therein, and the total length of the flexible catheter is defined as the distance between its proximal and distal ends, and the flexible catheter has an insertion portion that is inserted into the patient's body. And the insert extends from the tip to a point shorter than the proximal end, the heat exchanger has a plurality of heat exchange fins extending from the surface of the heat exchanger, and the heat exchange fins are increased to enhance heat exchange The heat exchanger has a surface area and functions to exchange heat between the body fluid that is in close proximity to the heat exchanger and the heat exchange fluid that circulates through the heat exchanger. And the first position is the entire position of the catheter. A plurality of sensors each of which senses data from a patient and produces a signal in response to the data, a manual input device by which an operator can specify a target parameter, a signal from the sensor and And a controller that receives the target parameter, is responsive to the signal, and controls the operation of each of the catheter devices in relation to the target parameter.

  The gist of a thirty-second aspect of the present invention is that the system according to the thirty-first aspect further includes a heat exchange unit, and the heat exchange unit functions to exchange heat with the heat exchange fluid.

The gist of a thirty-third aspect of the invention is that, in the system according to the thirty-second aspect, the heat exchange unit comprises a solid thermoelectric cooler.
The invention of claim 34 is the system of claim 32, wherein the target parameter is temperature, the sensor comprises a temperature sensor, and the controller can function to operate the heat exchange unit. The gist.

  The invention of claim 35 is the system of claim 31, wherein at least one catheter device provides heat to the bodily fluid at the first position, and at least one catheter device takes heat away from the bodily fluid at the second position. This is the gist.

  The present invention provides a heat exchange catheter device generally having an elongate flexible catheter with the same heat exchanger that functions to exchange heat with blood or other body fluids that flow in close proximity to exchange heat. provide. The present invention relates to specific regions of the body of a mammalian patient (eg, brain, selected parts of the brain, spinal cord, organ, intraperitoneal organ, spleen, liver, heart, part of heart, lung, kidney, muscle, tumor, trauma The present invention relates to a method of using such a heat exchange catheter device for selectively heating or cooling the site where the occurrence occurs.

  According to the apparatus of the present invention, i) an elongate catheter having a proximal end and a distal end, and the total length of the flexible catheter is defined as the distance from the proximal end to the distal end; and ii) heat exchange At least one fluid lumen through which fluid can circulate; and iii) a heat exchanger with heat exchange fins disposed in a first position on the catheter, extending from outside the patient and inserted into the patient A heat exchange catheter device is provided that may generally comprise a working lumen through at least a portion of the catheter. The heat exchanger functions to exchange heat between blood in close proximity to the exchanger and heat exchange fluid that circulates through the catheter. The “first position” where the heat exchanger is disposed is configured to be shorter than the entire length of the catheter, and is usually at or near the distal end of the catheter. The heat exchanger may particularly comprise a balloon or other structure through which heat exchange fluid can be circulated. The heat exchange fins can be multiple lobes of the balloon to increase the efficiency with which heat exchange occurs, or protrusions (eg, outwardly extending protrusions, ribs, etc.) that increase the surface area. Also, in some embodiments of the catheter device, a body fluid guiding sleeve is formed around the portion of the catheter where the heat exchanger is located (and can extend a certain distance from the heat exchanger to the proximal side) Blood or other bodily fluids that are in close proximity to heat exchange with the exchanger may be induced. Such a bodily fluid guiding sleeve allows the available bodily fluid (eg, blood) to pass from a certain anatomical conduit (eg, the descending aorta) where the proximal end of the sleeve is located to which the distal end of the sleeve is located. Can be used to guide up to two anatomical conduits (eg, carotid artery). The sleeve may be sized and shaped to form a shoulder that forms a tight seal between the outside of the sleeve and the second anatomical conduit.

  Further, the catheter device may be provided in combination with a device (such as a guidewire or embolectomy catheter) or an agent (such as a thrombolytic or barbiturate) that is inserted into the working lumen.

  The catheter device of the present invention may further include a curved heat exchange balloon having an insulating surface and a heat transfer surface, and blood flowing to the brain passes through the heat transfer surface and blood flowing to other regions of the body is an insulating surface. Can be arranged to pass through.

  Finally, another aspect of the present invention is a catheter device in combination with a control system that senses a body condition such as temperature and controls the catheter in response to the sensed body condition. Such controls include turning the heat exchanger on and off when the patient's target area reaches a preselected temperature, and reactivating the heat exchanger when the temperature deviates from the preselected temperature.

In accordance with the method of the present invention, a method is provided for adjusting or changing the temperature of a selected area of a mammalian patient's body. Such a method includes the following steps.
a. A catheter device having the characteristics described above is inserted into the anatomical conduit of the patient's body through which the body fluid is flowing through the anatomical conduit of the patient's body to the selected region and selected through the anatomical conduit Positioning the catheter so that bodily fluid flowing to a region passes in close proximity to heat exchange with the heat exchanger before reaching the selected region; b. Using the heat exchanger of the catheter device, the temperature of the body fluid passing in close proximity to the heat exchanger is changed, and then the body fluid changes the temperature of the selected region of the patient's body. Process.

  Furthermore, according to the method of the present invention, a catheter device is disposed in a blood vessel that communicates with the brain (for example, the right common carotid artery, the left common carotid artery, the innominate artery, the right internal carotid artery, the left internal carotid artery). The device may be used to cool the brain or part of the brain to prevent nerve damage after a stroke or other injury (eg, ischemic organs, hypoxia, bleeding, trauma, etc.).

  Further in accordance with the method of the present invention, a body fluid (eg, blood) flowing to a selected body region is selectively heated or cooled, followed by such body fluid flowing from the selected body region. In order to return to the original temperature at or close to the original temperature, two or more catheter devices having the characteristics described above are simultaneously placed at different sites within the patient's body. In this regard, a heat exchange catheter device is placed in the artery to reheat the blood after it has circulated in the brain in order to cool the brain after it has been perfused and suffered from a stroke or other injury. Because of this, a second catheter is placed in the inferior vena cava or other appropriate vein to heat the blood flowing through the patient's body trunk and maintain the body at a normal temperature outside the cooling zone. Can be placed.

  Another aspect of the present invention provides a method of controlling heat exchange using body fluids so that a predetermined temperature can be set or maintained at the target tissue. As a further aspect, a predetermined temperature is set for the target tissue (eg, a specific hypothermic temperature is set for the brain), and another temperature is selected for another region (eg, core temperature is normal) The two catheters are controlled simultaneously to maintain both pre-selected temperatures.

  Further aspects and details of the invention will be apparent to those of ordinary skill in the relevant art upon reading and understanding the detailed description of the preferred embodiments set forth herein below. Each of the embodiments disclosed below may be considered alone or in combination with any other variations and aspects of the invention.

  According to the present invention, in order to change the temperature of a target region in the body, a catheter device capable of exchanging heat in situ using a body fluid and a system including the catheter device are provided. In addition, a controllable system has been provided in which a device that predictably and selectively affects the temperature of a patient's target site is associated with feedback data obtained from the patient.

The figure which shows the catheter of this invention percutaneously inserted in the blood vessel of a patient. FIG. 4 shows a catheter where heated or cooled fluid flows through the balloon, where the balloon provides an increased surface area near the tip of the catheter. The figure which shows the catheter provided with the resistance heating body of a front-end | tip, and the balloon which has a longitudinal direction rib for further increasing a heat-transfer surface area. The figure which shows the catheter which has a longitudinal direction fin at the front-end | tip of a catheter main body. The figure which shows the catheter which has a radial direction rib in the front-end | tip of a catheter main body. The figure which shows the catheter which has a helical fin for increasing the heat-transfer area at the front-end | tip of a catheter. The flowchart explaining the control mechanism of this invention. 6 is a schematic diagram of the temperature of the target tissue under the influence of the control mechanism of FIG. FIG. 4 illustrates a preferred catheter for selectively heating and cooling a patient's blood flow using a wire coil resistance heater and a metal foil cooler. The figure which shows the front-end | tip of the catheter of this invention inserted in the blood vessel of a patient. FIG. 9 is a cross-sectional view of the catheter of FIG. 8 taken along line AA showing the temperature change region. 1 is a side view of an exemplary catheter for heating or cooling fluid passing through an internal lumen of the present invention. FIG. FIG. 10 is a more detailed view of a catheter tip similar to that shown in FIG. 9; FIG. 6 is a side view of an alternative catheter for heating fluid passing through the inner lumen of the present invention. FIG. 12 is a side view of the catheter of FIG. 11 taken along line AA. FIG. 10 is a side view of another alternative embodiment of a catheter for heating or cooling fluid passing through an internal lumen having a plurality of perfusion orifices for injecting bodily fluids into the internal lumen of the present invention. FIG. 12 is a similar view of the catheter showing multiple flaps that are closed to prevent the inflow of bodily fluid into the internal lumen as fluid is injected into the internal lumen from the outside. FIG. FIG. 14 shows the catheter similarly shown in FIG. 13, showing the flap open to allow fluid to flow into the internal lumen when fluid is not injected from the outside into the internal lumen. FIG. 2 is a perspective view of a heat transfer catheter system coupled to a patient that may include a monitoring device, a control device, and a thermal catheter having a plurality of heat transfer sections. 1 is a schematic perspective view of a heat transfer catheter having a control device, disposable parts, reusable parts, heat exchange balloon catheter and various sensors. FIG. The schematic perspective view of the deformation | transformation heat transfer catheter of this invention arrange | positioned in the left common carotid artery. 1 is a schematic perspective view of a distal end portion of a finned thermal balloon catheter according to one aspect of the present invention having a balloon heat transfer portion for supporting circulation of heat transfer fluid. FIG. FIG. 18B is a schematic cross-sectional view of the catheter shown in FIG. 17B taken along line CC. FIG. 18B is a schematic cross-sectional view of the catheter shown in FIG. 17B taken along line DD. FIG. 18B is a schematic cross-sectional view of the catheter shown in FIG. 17B taken along line EE. 1 is a schematic perspective view of a modified heat transfer catheter of the present invention placed in the aorta, innominate artery, and right common carotid artery. FIG. 18B is a detailed perspective view of the heat transfer catheter of FIG. 18A formed using a blood guide sleeve defined by an opening that can communicate with a fluid-containing body region. FIG. 18B is a schematic cross-sectional view of the catheter shown in FIG. 18B taken along line CC. FIG. 18B is a schematic cross-sectional view of the catheter shown in FIG. 18B taken along line DD. FIG. 18B is a schematic cross-sectional view of the catheter shown in FIG. 18B taken along line EE. FIG. 18B is a schematic cross-sectional view of the catheter shown in FIG. 18B taken along line FF. FIG. 18B is a schematic cross-sectional view of the catheter shown in FIG. 18B taken along line GG. 1 is a schematic illustration of a heat transfer catheter shown in the aorta having a blood guiding sleeve with a proximal opening in the descending aorta and a distal opening in the left common carotid artery. 1 is a schematic perspective view of a modified heat transfer catheter of the present invention formed using an elongate shaft and a tapered catheter body with helical fins disposed in the aorta and the left common carotid artery. FIG. FIG. 6 is a schematic perspective view of another deformed thermal catheter formed using an occlusive shoulder and a valve assembly. FIG. 21B shows a proximal or distal valve in a closed position for a thermal catheter of the type shown in FIG. 21A. FIG. 21B shows a proximal or distal valve in an open position for a thermal catheter of the type shown in FIG. 21A. FIGS. 21A-D are graphs of the cardiac cycle and aortic blood flow measured for the synchronous opening and closing of the sleeve valve shown in the same way. 1 is a heat transfer catheter having a plurality of heat transfer regions that may be designed for placement in the aortic region. FIG. FIG. 5 is a schematic perspective view of one variation of the heat transfer catheter of the present invention having an inlet for cooling blood into the central lumen with the tip inserted into the coronary ostium. FIG. 30 is a cross-sectional view of FIG. 29 taken along line BB. FIG. 6 is a schematic perspective view of a finned thermal balloon catheter, where the fin is an inflatable balloon lobe. FIG. 24B is a schematic cross-sectional view taken along line BB in FIG. 24A. FIG. 24B is a schematic cross-sectional view taken along line CC in FIG. 24A. FIG. 24B is a schematic cross-sectional view taken along line DD in FIG. 24A. FIG. 24B is a schematic cross-sectional view taken along line EE in FIG. 24A. FIG. 24B is a schematic cross-sectional view taken along the line FF in FIG. 24A.

  The present invention is for selectively adjusting local and systemic body temperature by heating or cooling a body fluid such as blood in situ and directing the heated or cooled body fluid to a desired location. Methods and apparatus are provided. In accordance with the present invention, a catheter having a heat exchanger, which can be, for example, a finned balloon, is inserted into a fluid-containing part of a patient's body, such as a blood vessel. Mounted on the heat exchanger is a blood guide sleeve that opens both at its proximal end (closest to the insertion position) and its distal end (farthest from the insertion position along the catheter). ing. The distal end of the sleeve is arranged so that a fluid such as blood entering from the proximal end of the sleeve flows through the heat exchanger and close to the heat transfer body. Proximity for heat exchange requires sufficient proximity to produce effective heat exchange. Proximity for heat exchange includes the chemical and physical composition of blood, the speed of flow through the heat exchange surface, the pattern of blood flow through the heat exchanger (stratified flow, turbulence, etc.), the heat exchange surface and the blood Depending on factors such as the temperature difference between the two, the material of the heat exchange surface, and the proximity between the heat exchange surface and the blood. The fluid exits the tip of the sleeve so that heated or cooled blood is drained upstream of the desired location, eg, target tissue such as the brain. By continuing to heat or cool the fluid flowing toward the target tissue for a sufficient length of time, the temperature of the target tissue is changed.

  Further, when inducing hypothermia or hyperthermia, the present invention prepares to heat or cool the target tissue to the desired temperature and maintain that temperature by controlling the heat exchange catheter. Similarly, by controlling different heat exchange catheters at different locations within a patient's body, different regions may be maintained adjustable to different temperatures. In addition, using a separate heat exchange catheter, or an additional heat exchange area located on the same heat exchange catheter, while maintaining the target tissue temperature at a desired temperature, eg, moderate hypothermia, the core temperature Can be monitored and maintained at different temperatures, eg, normal temperature (37 ° C.) or near normal temperature.

  FIG. 1 shows the distal end portion 15 of the heat exchange catheter 10. The catheter may be inserted into the blood vessel BV through the patient's skin. In FIG. 1, the blood flow flowing in the blood vessel is indicated by a set of flow arrows F. The catheter can be inserted into relatively large blood vessels, such as the femoral artery or vein, the jugular vein. This is because these vessels are easily accessible, provide a safe and convenient insertion site, and offer many advantages of relatively large amounts of blood flowing. In general, higher blood flow rates result in faster heat transfer to or from the patient. For example, the jugular vein may have a diameter of about 22 French, that is, slightly larger than 7 mm (1 French = 1 mm / π). A catheter suitable for insertion into a blood vessel of this size can be made considerably larger than a catheter for insertion into other areas of the vasculature. Atherotomy or balloon angioplasty catheters may be used to remove obstructions from coronary arteries and similar vessels. These catheters generally have an outer diameter in the range of 2-8 French. However, although catheters formed in accordance with this aspect of the present invention may have an outer diameter of about 10 French or greater, it is clear that this dimension can vary significantly without departing from the basic principles of the present invention. is there.

  The catheter can be made small enough to be inserted into the puncture site using the percutaneous Seldinger method, a method well known to medical professionals. In order to avoid vascular trauma, the catheter will typically have a diameter of less than 12 French when inserted. However, once inside the blood vessel, the tip or working end of the catheter may be enlarged to any size as long as it does not excessively impede blood flow. In addition, the femoral artery and vein and the jugular vein are relatively long and straight blood vessels. For this purpose, a catheter having a fairly large temperature control region can be conveniently inserted. Of course, this is advantageous in that if the length of the heat transfer region is increased, a catheter having a given diameter can transfer more heat at a given temperature. Methods for inserting a catheter into the blood vessel described above are well known among medical professionals. Although the method of the present invention is probably the most commonly used in hospitals, the procedure need not be performed in the operating room. The device and procedure are so simple that in some cases, even in an ambulance or outdoors, a catheter can be inserted and the procedure initiated.

  FIG. 2 shows yet another means for transferring heat to or from the tip of the catheter. In this embodiment, the catheter shaft 20 has two lumens extending therethrough. The fluid flows from the proximal end of the catheter through the inflow lumen 60 through the heat transfer region 62 and out through the outflow lumen 64. By supplying a heated or cooled fluid through the inflow lumen 60, heat can be transferred to or from the patient's blood stream that flows in close proximity to the heat transfer region 62. The heat transfer area 62 may be in the form of a balloon 70. The use of a balloon may be advantageous in some embodiments with an increased surface area that can cause heat transfer. Balloon inflation is maintained by the pressure differential of the fluid as it flows through the inflow lumen 60 and the outflow lumen 64. The balloon needs to be inflated to a diameter somewhat smaller than the inner diameter of the blood vessel so as not to unduly hinder blood flow through the blood vessel.

  FIG. 3 shows a catheter having an internal resistance heater 28 and a balloon 70 shown in an inflated state. The surface of the balloon is provided with structures that increase the surface area available for heat transfer, i.e. fins. In this embodiment, the increased surface area provided by the inflated balloon is increased by the presence of a set of longitudinal fins 75 on the balloon surface. As shown in FIGS. 3 and 4A-C, longitudinal fins 75, radial ribs 77, or one or more helical fins 79 may be placed directly on the catheter body 20. Longitudinal ribs may be advantageous because they are less prone to restrict blood flow through blood vessels than those of other shapes. In fact, these ribs ensure that the blood flow through the blood vessels is not substantially blocked because passages can be maintained between the ribs even when the balloon is inflated. By adding a balloon over a catheter that uses a resistance heating element, it is possible to design a current to flow through the fluid filling the balloon.

  The catheter of the present invention can be designed and formed to optimize the heat transfer rate between the catheter and blood flowing through the blood vessel. Although a large surface area is desirable to maximize heat transfer, the catheter needs to be of an appropriate shape and size to minimize the restriction on flow through the vessel. Furthermore, the temperature of the catheter must be carefully controlled to prevent unwanted chemical changes in the blood. This is particularly important when applying heat to the blood, as blood is easily denatured even by moderately high temperatures. The outer surface temperature of the catheter for heating the blood generally should not exceed about 42-43 ° C. In patients starting with severe hypothermia, it is estimated that a catheter whose surface temperature is controlled at 37-42 ° C. will provide a core heating rate of about 1-2 ° C. per hour. This estimate is highly dependent on many factors, including the speed of blood flow through the blood vessel, the patient's initial body temperature, the external surface area of the catheter that transfers heat, and the like. The actual speed achieved can be substantially different from the above estimate. The estimate provides a starting point for obtaining an approximate estimate of the level of power transferred from the catheter to the patient's body and thus the amount of power required by the system. Regardless of the specific power transmission method selected, a resistive heating coil, laser and diffusion tip, direct transmission or fluid circulation, and appropriate power supply are required to supply and remove heat from the system. It will be necessary.

The total heat coming in and out of the patient ’s body is
_{ΔH = H c + H i -H} e
(Wherein, [Delta] H is the total, H _c of all heat transferred in the heat transferred to the patient from the catheter, the heat H _i is generated in the body of a patient, the H _e lost to the environment from the patient Heat)
Can be expressed as Usually, as in the case of a healthy patient, if the body temperature regulation system produces enough heat to just make up for the heat lost to the environment, the formula becomes simple.

ΔH = H _c
The above equation can be expressed as follows regarding the change in the internal temperature of the patient over time.
mc (ΔT / Δt) = (ΔH _c / Δt)
(Where m is the patient's weight, c is the specific heat of the patient's body, (ΔT / Δt) is the time rate of change of the patient's body temperature, and (ΔH _c / Δt) is the time of heat delivery from the catheter to the patient. Speed). Estimating a patient with a body weight of 75 kg and a specific heat of 4186 Joules / ° C-kg (assuming that the specific heat of the human body and the specific heat of water are the same, the actual values will be somewhat different) per hour (3600 seconds) A heating rate of 1 ° C. would require a catheter that transfers heat to the patient at a rate of about 87 watts (1 watt = 1 joule / second). However, this estimate would be too low for an estimate for the desired size of the power source used with the catheter of the present invention. This can be predicted for a number of reasons. First, for the sake of convenience, it was estimated that the patient's body system produced a heat quantity equal to the amount lost to the environment. This is clearly not the case for patients with hypothermia. Most obviously, incidental hypothermia occurs when the ability of the human body to generate heat is overwhelmed by heat lost to the environment. The catheter must make up for this difference, so the required power level needs to be high for that reason alone. Alternatively, to induce hypothermia, remove enough heat from the blood to lower the temperature of the target tissue, or in the case of systemic hypothermia, more heat than the body produces. It will need to be removed. When reducing heat, the power required to cool the heat exchanger is highly dependent on the efficiency of the cooling device, including the dissipation of excess heat from the device to the environment.

  The estimated value does not take into account the power loss between the power source and the heating means used. Such losses include power lines between the power source and resistance heaters, inherent inefficiencies and other losses in systems with lasers and diffusion tips, heat losses along heat transfer shafts or fluid circulation lumens, etc. Can be included. Any such loss that actually occurs needs to be compensated by additional feed capacity. Furthermore, it is undesirable to limit the performance of the catheter of the present invention by limiting the size of the power source used. Instead, it is preferable to use a power source that can provide much more power than is actually needed and then control that power according to the measured temperature of the catheter itself. As previously mentioned, this can be easily accomplished by including a sensitive temperature sensor within the catheter body. However, the above calculations can be used as an expected lower bound estimate useful for determining the size of a power source for use with the catheter of the present invention.

  Alternative estimates can be calculated by comparing the predicted performance of the various embodiments described herein with the power requirements for known external blood heating devices. Such external heating devices generally require a power supply on the order of 1000-1500 watts, and sometimes more. Devices formed in accordance with the present invention require significantly lower power. First, the present invention does not require an external pump for circulating blood. This function is provided by the patient's own heart. Therefore, no power is required to drive such a pump. Second, the present invention is considerably simpler than an external blood heating system. In known systems, blood is circulated over a relatively long path from the patient through the heating element and back to the patient. Over such a long path, more heat will be lost than in the device described herein. Thus, the power required by known types of external blood circulation and heating systems can be used as an approximate estimate of the expected upper limit of power required by the system of the present invention. Such a system is most suitably equipped with a power supply having a capacity between the two approximate estimates. Thus, it is expected that a suitable power source can provide peak power in the range of 100-1500 watts, perhaps in the range of 300-1000 watts. The specified range is an estimate of a suitable peak power capacity. The power supply is most commonly thermostat controlled in response to a temperature sensor within the catheter body. Thus, the actual active power delivered to the patient is usually much less than the peak power capacity of the system power supply.

  The above calculations relate primarily to a system for heating blood. With respect to catheters for cooling blood, the temperature and power constraints should not be extreme. Care must be taken to avoid excessively rapid cooling to freeze the blood and cause shock to the patient. The main component of blood is essentially water containing many suspended and dissolved substances. As such, its freezing point is somewhat below 0 ° C. However, catheters adapted to cool the blood of hyperthermia patients or induce artificial hypothermia will usually not be operated at such low temperatures. While the outer surface of such a catheter can be kept in the range of about 1-20 ° C, it is currently expected that the actual temperature may vary between about 0 ° C and the patient's current body temperature. The Further, for example, in the case of a heat exchange balloon having a significant length, the surface temperature of the balloon can vary along its length when dissipating heat into the blood. The balloon can have a temperature change of 12 ° C. or more along its length.

  According to another aspect of the present invention, the body temperature of an initially hypothermic patient must be increased, or initially must be hyperthermia or be reduced below normal for some other purpose. Further provided is a method for reducing the body temperature of a patient who must not. In such cases, in general, the desired temperature is, for example, systemic in the case of systemic hypothermia and, for example, in the brain in the case of local hypothermia, so as not to exceed the physiological response of the patient. It is necessary to monitor the target tissue and control the cooling. In such cases, this aspect of the invention is particularly adapted to reverse the heat transfer process to maintain the target tissue at a selected body temperature.

  As described in FIG. 5, a sample control mechanism is provided herein for heating or cooling a target tissue to a preferred temperature and maintaining the target tissue at its substantially preferred temperature. The control mechanism will be described with reference to the flowchart shown in FIG. 5 and the graph shown in FIG. As the target temperature, a preferable temperature, for example, 31 ° C. in the case of brain tissue is selected in advance. In the case of a heat exchange catheter, this preselected temperature is transmitted to the control device, for example, by setting a desired temperature on the control device for the heat heat exchange catheter. A heat exchange catheter capable of removing heat from the blood or applying heat to the blood is inserted so as to be close to the blood in a blood vessel that supplies the blood to a target position such as the brain. The catheter is controlled by the controller, which can control the heat exchanger to heat or cool the blood in close proximity to exchange heat with the heat exchanger.

  The temperature of the brain is monitored, for example, by a temperature probe inserted into the brain tissue or by measuring the temperature at a surrogate location such as the eardrum, or the nasal cavity provides a temperature measurement that represents the temperature of the brain. Thereby, the detected temperature measurement value is obtained and transmitted to the control device. For example, the upper dispersion set value is set to ½ ° C. above a preselected temperature, and this is transmitted to the controller. In this example, this results in an upper dispersion set point of 31 1/2 ° C. For example, when the lower dispersion set value is also set to ½ ° C. below the preselected temperature and is transmitted to the control device, the lower dispersion set value is 30 ½ ° C. in this embodiment.

  When the heat exchanger is cooling, the detected temperature of the target tissue is compared to a preselected temperature. If the detected temperature is higher than a preselected temperature, cooling continues. If the sensed temperature is at or below a preselected temperature, the controller operates to switch off the heat exchanger. After switching off the heat exchanger, the temperature of the target tissue is measured again to obtain the sensed temperature. If the sensed temperature is higher than the upper dispersion setpoint, the controller operates to cause the heat exchanger to restart cooling. This cooling continues until the temperature reaches a preselected temperature again. At this point, the controller operates once more to switch the heat exchanger off. If the patient's body is generating heat at the target tissue at a rate greater than the rate of loss to the environment, the temperature is between the preferred temperature and the upper dispersion setpoint, in this example shown in section A of FIG. As you can see, it swings between 31-31 1/2 ° C.

  In some cases, after the heat exchanger is switched off, for example, if the brain tissue is releasing more heat to the environment than the heat it produces, the temperature of the target tissue will continue to drop naturally. I will. In such a situation, the detected temperature continues to drop until it falls below the lower dispersion setpoint. The controller then activates the heat exchanger to apply heat to the blood and thus to the target tissue until the sensed temperature is again at a preselected temperature. The controller then switches off the heat exchanger. When the temperature drops again below the lower dispersion set point, the above process is repeated. When this situation is repeated, the temperature is between the preselected temperature and the lower dispersion set point, in this example between 31-30 1/2 ° C. as shown in section B of FIG. You will see that it swings.

  The examples presented herein are for illustrative purposes only, and many variations are anticipated within the scope of the present invention. For example, preselected temperatures and upper and lower dispersion setpoints may differ from those described above. The above description is an example of cooling the target tissue to a temperature below normal temperature. However, a preselected temperature above normal temperature may be selected, or a heat exchanger controlled to heat or remove blood from the blood may be controlled by a similar control mechanism to control the temperature of the target tissue. It will be appreciated that the pre-selected temperature above normal temperature within the upper and lower dispersion setpoint ranges can be maintained. In the illustrated control mechanism, a hypothermic patient can be reheated to normal temperature by setting the preselected temperature to 37 ° C. and causing the heated body to heat the blood until the detected temperature reaches 37 ° C. It will be easily understood. Prediction and prevention of temperature overshoot can be accomplished as described in US patent application Ser. No. 08 / 584,013, previously incorporated herein by reference.

  In the example shown, all steps such as measuring the temperature of the target tissue or comparing the sensed temperature with a preselected temperature are all described as separate actions, but those skilled in the art will consider their actions relative to each other. It will be readily understood that it may be continuous. It is also possible to replace and adjust regulation criteria other than the temperature of the target tissue, such as blood pressure or intracranial pressure, or temperature derived from other locations, for example, cooling a region such as the brain and comparing that region In order to maintain the patient's core temperature to a normal temperature and maintain the patient's core temperature relatively stable at the normal temperature, while maintaining a stable cooling state, the two control mechanisms described are It will also be readily appreciated that it may be initiated simultaneously for different locations within the patient's body. The above method of causing a change in the temperature of the target tissue was to cool the blood upstream from the target tissue, but other heating and cooling methods such as heating the cerebrospinal fluid circulating around the brain or spinal cord or It will be appreciated that cooling may be used.

  A patient selective heating and cooling system is shown in FIG. The system may include a catheter 100 having a proximal end 102, a distal end 104, a heat generating surface 106 near the distal end, and an endothermic surface 108 near the distal end. The heating surface 106 may include any of the heat transfer components described above, particularly a wire coil resistance heater, shown with 50 to 1000 windings typically spaced 0.1 to 1 mm apart. . The total length of the catheter can range from 15-50 cm and the diameter can be about 1-5 mm. The winding extends over the entire distance in the range of 10-20 cm near the tip. The endothermic surface can typically be a heat transfer metal foil made of a biocompatible heat transfer metal such as gold, silver, aluminum or the like. Copper can also be useful, but processing or encapsulation is required to enhance its biocompatibility. The metal foil may be thin to increase the flexibility of the catheter body, which typically has a thickness in the range of 0.001 to 0.01 mm. The endothermic surface 108 may be electrically coupled to a cooler within the controller 120, typically described below, located outside the catheter. In the illustrated embodiment, the surface 108 is joined by a thermally conductive core member 110 consisting of a flexible rod or wire formed from one of the aforementioned thermally conductive metals. Alternatively, the surface 108 can be stretched proximally to achieve thermal coupling so that the proximal end of the surface 108 can be coupled to the cooler. In the latter case, the proximal end of the surface 108 is preferably insulated to prevent cooling outside the blood circulation. The system further includes a controller 120 that typically provides both a heater and a cooler for coupling to the catheter 100. The heater may further comprise a direct current power source for coupling to a resistance heater on the catheter. Typically, the direct current source will typically be a commercially available temperature controlled DC power supply operating at a voltage in the range of 10-60 VDC and a current output of 1-2.5A. The power source may be controlled to maintain the surface temperature of the heat generating surface 106 in the range of 40-42 ° C. As mentioned above, the surface temperature should not exceed 42 ° C. to prevent damage to blood components. Other desirable features of the heat exchange surface have been described above.

  Alternatively, the temperature of the heat exchange surface can be controlled based on the measured blood temperature and / or measured body temperature. The blood temperature can be measured with a temperature sensor present on the catheter. For example, the temperature sensor 112 may be spaced from the heat exchange surfaces 106 and 108 on the catheter. The temperature sensor 112 may be located upstream or downstream of the heat exchange surface based on the direction of blood flow and depending on the manner of introduction of the catheter into the patient. Optimally, a pair of temperature sensors may be placed, one on each side of the heat exchange surface, to measure upstream and downstream blood temperatures. The catheter may further comprise a temperature sensor (not shown) coupled directly to the surface 106 so that the temperature of the heat generating surface 106 can be directly controlled. Other temperature sensors (not shown) may be provided that directly measure the patient's core temperature or the temperature of various regions within the patient's body, and the measured temperature is fed back to the controller 120. The cooler in the controller 120 can be any type of cooling device that can remove heat from the endothermic surface 108 at a rate sufficient to cool the blood at a desired rate. Typically, the cooler is rated at 150-350W.

  The cooler is a thermoelectric cooler such as that available from Melcor Thermoelectrics, Trenton, New Jersey 08648, Trenton, NJ. The cooler may be coupled directly to the core member 110 such that direct heat transfer from the endothermic surface 108 is provided to the cooler in the controller 120. The temperature of the cooling surface 108 is less important than the temperature of the heating surface 106 for this aspect of the invention, but will typically be maintained in the range 0-35 ° C, preferably less than 30 ° C. The temperature of the cooling surface may be controlled directly within this range, or the system may be designed so that the cooling temperature functions within approximately this range based on overall system characteristics.

  The controller 120 may further comprise one or more temperature controllers for controlling the temperature of the heat generating surface 106 and the heat absorbing surface 106 based on blood temperature and / or body temperature. At least, the controller 120 controls the temperature of the heat generating surface 106 within the above range and monitors at least one of the patient's blood temperature and the patient's body temperature to reverse the heating or cooling mode as described above. obtain. For example, with respect to the control mechanism described in FIG. 10, for example, the system may be operated in an on-off mode that first warms and treats a hypothermic patient at a constant surface temperature rate until the target temperature is reached. When the target temperature is reached, the power to the heat generating surface 106 is switched off. However, blood and / or patient temperature monitoring is continued to ensure that the patient's body temperature does not exceed a maximum value above the target temperature. If the maximum value is exceeded, operate the system in cooling mode until excessive body temperature drops. Usually, it is not necessary to heat the patient again, but the system of the present invention can provide additional cooling and heating cycles if necessary. For patients with early hyperthermia, the cooling and heating modes are reversed. It will be appreciated that the temperature control mechanism of the present invention may be substantially more sophisticated. For example, the input to heat the patient typically includes a proportional control mechanism, an induction control mechanism, or a progressive control mechanism that gradually decreases the heat transfer rate as the patient's core or local body temperature approaches a desired target level. Control may be based on an integrated control mechanism. Furthermore, a cascade control mechanism based on the patient's blood temperature and the patient's body temperature can be devised. For example, such a control mechanism can be adapted to heat or cool the patient in preparation in a mathematical model that takes into account typical patient physiological characteristics. However, if the target temperature exceeds a safe amount, a simple on / off control mechanism that can reverse the heat transfer mode will suffice.

  Another aspect of the invention provides a method and apparatus for adjusting the temperature of a fluid delivered to a target location within a patient's body while the fluid is in the body. Regulating fluid temperature in this manner is useful for a variety of applications, including heating or cooling the temperature of drugs, solutes or blood before they are delivered to the target site. Adjusting the temperature of the injected fluid is also useful for adjusting the temperature of the target location itself in preparation for various medical procedures, including neurosurgical procedures in the brain. In addition, such methods and devices can control the temperature of the tissue within the patient's temperature range by heating or cooling the patient's blood in situ. By heating or cooling the patient's blood and then flowing through the target tissue, the temperature of the tissue can be raised or lowered as desired. Accordingly, such methods and devices provide a convenient therapy for the treatment of hypothermia or hyperthermia, or induction of local cooling or heating.

  FIG. 8 illustrates a tip 210 of a catheter 212 formed in accordance with another aspect of the present invention. The catheter 212 may be placed in the blood vessel BV. The blood flow through the blood vessel is indicated by a set of arrows F in FIG. It will be appreciated that the distal end 210 of the catheter 212 may include a temperature changing region 214, which may be located anywhere between the proximal and distal ends of the catheter. Methods for inserting catheters into various blood vessels, such as the Seldinger method referred to above, are well known among medical professionals. The catheter 212 can be manufactured in various sizes depending on the particular application. For most uses, the length may range from about 30 to about 130 cm and the diameter may be 6-12 French (1 French = 0.33 mm). The catheter 212 can be moved through various blood vessels in the patient's body and is preferably flexible so that it can be placed in the body with the aid of a guide wire.

  As shown in FIG. 9, the catheter 212 has an internal lumen 216. A temperature changing mechanism 218 may be deployed adjacent to the lumen wall of the inner lumen 216 of the temperature changing region 214. For convenience of explanation, the temperature change mechanism 218 is shown schematically, but the mechanism 218 is a lumen of the inner lumen that heats or cools fluid passing through the inner lumen 216 in the temperature change region 214. Various mechanisms used to heat or cool the wall 216 may be provided. A typical mechanism for heating or cooling the lumen wall is supplied to heated or cooled fluid passing near the lumen wall of the catheter 212, a resistor disposed within the catheter 212, and a temperature change region. Laser energy, various chemicals disposed within the catheter body, thermoelectric crystals, and the like may be provided. With such a mechanism, the temperature of the fluid in the temperature change region that passes through the inner lumen 216 can be varied to be within a desired temperature range as the fluid exits the catheter 212. The temperature change mechanism 218 may be configured to heat the temperature of the fluid passing through the temperature change region from 5 to about 42 ° C. When cooling the fluid, the temperature change mechanism 218 may be configured to cool the fluid from 7 to about 30 degrees Celsius. The temperature changing mechanism 218 may be designed to optimize the heat transfer rate between the catheter and the fluid flowing through the inner lumen. In addition, the temperature of the catheter can be carefully controlled to prevent undesirable chemical changes in the blood. This is particularly important when applying heat to blood, as blood is easily denatured even by moderately high temperatures. The temperature of the lumen wall for warming blood generally should not exceed about 42-43 ° C. The amount of energy that can be delivered to increase the core temperature of a patient is described in US Pat. No. 5,486,208, which is already incorporated herein by reference. The temperature changing mechanism 218 may also be disposed within the catheter 212 so that the temperature of the lumen wall can be heated or cooled without substantially directly heating the outer surface of the catheter 212. In this way, the catheter 212 can be selectively heated or cooled using the catheter 212 simply by placing the tip of the catheter at a specific target site and introducing fluid into the internal lumen 216.

  As shown in FIGS. 9 and 10, a catheter 220 formed in accordance with this aspect of the invention may circulate heat transfer fluid to change the temperature of the fluid passing through the catheter. Catheter 220 includes a catheter body 222 having a proximal end 224 and a distal end 226. A lumen 228 extends between the proximal end 224 and the distal end 226. Proximal 224 has a proximal port 230 through which various fluids can be introduced into lumen 228 from outside the patient. Passing through the catheter body 222 are a first passage 232 and a second passage 234, particularly as shown in FIG. A first port 236 communicates with the first passage 232, and a second port 238 communicates with the second passage 234. In this manner, heated or cooled heat transfer fluid is introduced into the first port 236 and from there through the first passage 232 adjacent the lumen 228. As the heat transfer fluid passes through the first passage 232, heat is transferred to or from the fluid passing through the lumen 228, and the fluid is heated or cooled to the desired temperature before exiting the catheter body 222. . After passing through the first passage 232, the heat transfer fluid circulates back through the catheter body 222 and exits the second port 238 through the second passage 234.

  11 and 11A illustrate yet another variation of the present invention that includes a catheter having a resistance heating device that heats fluid passing through the catheter 240. Catheter 240 has a catheter body 242 having a proximal end 244 and a distal end 246. A lumen 248 passes between the proximal end 244 and the distal end 246 of the catheter body 242. A proximal port 250 is provided to facilitate introduction of fluid into the lumen 248 from outside the patient. A plurality of wires 252 are disposed near the lumen 248 of the catheter body 242 as shown in FIG. These wires 252 exit the catheter body 242 through port 254. The wire 252 may be connected to a DC power source or a low frequency AC power source. As the current passes through the wire 252, some of the energy is dissipated as heat to heat the lumen wall. Alternatively, a high frequency or RF power source that provides power to electrodes disposed within the catheter body 242 may be used to heat the lumen wall.

  With reference to FIGS. 12-14, the catheter 256 may be used to heat or cool externally injected fluid, to heat or cool body fluids in situ, or a combination of both. Catheter 256 can include a catheter body 258 having a proximal end 260 and a distal end 262. A lumen 264 extends between the proximal end 260 and the distal end 262, as shown in FIG. In addition, the proximal end 260 is also provided with a proximal port 266 through which various fluids can be injected into the lumen 264, but the port 266 is located outside the patient. The tip 262 has a temperature change region 268 that includes a temperature change mechanism (not shown). Particular temperature changing mechanisms may include those described above or below with respect to other aspects of the invention. In this manner, fluid injected into port 266 passes through lumen 264 and changes its temperature as it passes through temperature change region 268 in the same manner as previously described for other embodiments. Catheter body 258 may include a plurality of perfusion orifices 270 extending through the wall of the catheter body to provide a passage to lumen 264. As shown by the arrows in FIG. 12, bodily fluids such as blood pass through the orifice 270 and into the lumen 264, where the bodily fluid exits the tip 262 of the illustrated catheter body 258. Sometimes the temperature is changed in the temperature change region 268 so that the temperature of the body fluid is within the desired range.

  As shown in FIGS. 13 and 14, the lumen wall of the catheter body 258 may include a plurality of flaps 272. The passage of bodily fluids through these flaps 272 and into the lumen 264 from the orifice 270 may be controlled. These flaps 272 or similar structures may be configured as described in US Pat. No. 5,180,364, the disclosure of which is incorporated herein by reference. As shown in FIG. 13, due to the pressure and flow direction of the injected fluid so that only substantially injected fluid passes through the temperature change region 268 when injecting fluid from the port 266 into the lumen 264. Orifice 270 will be closed with flap 272 as shown. In this case, the temperature of the fluid being injected will be altered so that it is within the desired range as the fluid exits the tip. As shown in FIG. 14, when no fluid is injected into the port 266, body fluid pressure in the blood vessel opens the flap 272 and the body fluid flows into the lumen 264 through the orifice 270. In this manner, the temperature of body fluid such as blood can be changed by passing through the orifice 270 and passing through the temperature change region 268. This arrangement of the flaps 272 is particularly advantageous in applications that change the temperature of the patient's tissue. By simply introducing the catheter 256 into the patient, blood flowing into the lumen 264 through the orifice 270 will change temperature by the time it exits the tip 262. This can cause changes in body temperature throughout the body, and local changes in temperature can occur when blood is directed to a specific site by a catheter. If more solute or drug is needed for treatment, the solute or drug can be introduced into lumen 264 via port 266 and brought to a temperature that is substantially the same as the temperature of the outgoing blood. As mentioned above, this aspect of the present invention provides methods and apparatus useful for regulating the temperature of various fluids in the patient's body while they are present. With such a device, a variety of procedures can be performed, including the introduction of a drug or solute from outside the patient, which can change the temperature within the catheter before the drug or solute reaches the target location. Further, prior to performing a medical procedure, the fluid may be heated or cooled within the catheter, thereby heating or cooling specific areas of the body structure. In another alternative, the temperature of a patient's bodily fluids such as blood may be altered in situ to induce hypothermia or hyperthermia or to intentionally induce systemic or local hypothermia.

  Another aspect of the invention provides methods and devices for local and systemic temperature changes. Reducing the body temperature of the selected area may provide a neuroprotective effect, particularly close to the brain. A selected portion of the at least one catheter may cool a fluid, such as blood or cerebrospinal fluid, that contacts, circulates in or around the brain region, or flows into the brain region, for example. Chilled bodily fluids can be selectively directed to selected areas of the patient's body to produce locally limited cooling effects. Alternatively, the temperature of the patient's whole body can be lowered, for example, to provide neuroprotection for other wide areas of tissue, such as the entire brain and spinal cord. As described in further detail below, the methods and apparatus provided herein provide heat generated with increased surface area or finned portions to provide rapid and effective heat transfer. An exchange catheter may be provided. The locally confined heat transfer region along the catheter body having a certain longitudinal dimension further provides effective heat transfer with the fluid flowing in the internal passage, while the catheter further includes a catheter. Provides a local cooling or heat transfer zone along the selected portion. Various combinations of heating elements and cooling elements are formed along different portions of a catheter, or as part of a heat exchange device series or combination similarly described with respect to other aspects of the invention Can do. All of these devices and procedures are directed to local or selective temperature changes that are particularly suitable for cooling the cerebral area and inducing artificial hypothermia conditions that may provide therapeutic benefits in the treatment of cerebrovascular injury. The system can be a simple heat transfer catheter with manual control, using a controller that can monitor many sensors and control the heat exchange catheter in response to data received from these sensors. You may operate.

  As shown schematically in FIG. 15, a heat transfer catheter system in accordance with this aspect of the present invention includes a catheter controller 300 and a heat transfer catheter 302 configured to include a combination of one or more heat transfer portions. Can be provided. One or more heat transfer sections are located in the portion of the catheter that is inserted into the patient, shown in section 319. This insertion section is shorter than the total length of the catheter and extends from the position of the catheter immediately inside the patient to the tip of the catheter when the catheter is fully inserted. The catheter controller 300 may comprise a fluid pump for circulating a heat exchange fluid or medium within the catheter 302 and a combination of one or more heat exchange components for heating and / or cooling circulation fluid in the heat transfer system. . Controller 300 may be coupled to a container or fluid bag 306 for supplying a source of heat transfer fluid, such as a saline solution, a blood substitute solution, or other biocompatible fluid. The controller 300 may further include, for example, feedback or from a selected organ or selected part of the body such as a temperature probe 308 for the brain and head region, a rectal temperature probe 309, an ear temperature probe 311, a bladder temperature probe (not shown). Data may be received from a variety of sensors, which may be solid state thermocouples that provide patient temperature information. Based on the sensed temperature and condition, the controller 300 may command heating or cooling of the catheter in response to input from the sensor. The controller 300 activates the heat exchanger at the first detected temperature, and stops the heat exchanger at a second detected temperature that is relatively higher or lower than the first detected temperature or other preset temperature. obtain. Of course, the controller 300 can independently heat or cool selected heat transfer sections to achieve a desired or preselected temperature in the body region. In addition, the controller may activate one or more heat exchangers that control the temperature in specific areas of the patient's body. Also, the control device can activate or deactivate other devices such as an external warming blanket, for example, in response to the sensed temperature. The controller may function as described above and illustrated in FIGS.

  15 may also provide various cooling and / or heating zones by circulating a heat transfer medium through a series of inflow and outflow conduits. The first and second passages 312 and 314 may provide a heat exchange passage in the catheter and each has a suction port 315 for a heat transfer fluid circulation pump that cools the fluid flow in the selected body region, respectively. And can be connected to the outlet 317. Similar devices may be provided to heat selected body regions simultaneously or separately with the cooling components of the system. In addition, the catheter controller 300 includes a thermoelectric cooler / heater that is selectively activated and deactivated to perform both heating and cooling functions using the same or different heat transfer media within the closed loop catheter system. Can be prepared. For example, the first heat transfer portion 318 located on the insertion portion 319 of one or more temperature control catheters 302 circulates a cold solution in the adjacent head region or other blood vessels leading to the carotid artery or brain. obtain. Head temperature may be monitored locally by a temperature sensor 308 located relatively close to the patient's outer surface or within a selected body region. Another or second heat transfer section 320 of the catheter 302, which is also located on the insert 319, circulates the heated solution within the folding balloon or has been described according to other aspects of the invention. Heat may be supplied to other locations in the body via other mechanisms of heating. The heat transfer catheter 302 can provide local hypothermia to the brain area for neuroprotection, but other parts of the body can be kept relatively warm so that adverse side effects such as tremors can be avoided or minimized. . Further, heating around the bottom of the body's neck may be achieved by cooling the head region 310 above the neck while insulating or wrapping a relatively lower portion of the body within a warming pad or blanket 322. Of course, it is understood that the multiple heat transfer sections of the catheter 302 can be modified to change the core temperature to cool or heat the entire body and are not limited to local or localized thermoregulation. Should.

  FIG. 16 shows a heat transfer catheter system of the present invention that includes a heat transfer catheter 324, a disposable heat exchange plate 338, a pump head assembly 340, a saline solution bag 339, sensors 348, 349 and fluid flow lines. Disposable parts including 337 and reusable parts including solid state thermoelectric heater / cooler 342, pump driver 343 and various device controllers.

  The heat transfer catheter 324 is formed using a blood guide sleeve 325, a catheter shaft 326, and a heat exchanger 327, which can be, for example, a heat exchange balloon that is operated using a closed loop flow of heat exchange media. The catheter shaft is formed with a working lumen 328 for receiving a guidewire 329 for injecting drugs, fluoroscopic dyes, etc., and placing the heat transfer catheter in the appropriate location on the patient's body. Can do. The proximal end of the catheter shaft may be coupled to a multi-arm adapter 330 for separately accessing various passages within the shaft. For example, one arm 336 may provide access to the central lumen 328 of the catheter shaft to insert a guide wire 329 and advance the heat transfer catheter to a desired position. If the heat exchanger 327 is a heat exchange balloon for a closed loop flow of the heat exchange medium 331, the adapter includes an arm 332 that connects the inflow channel 333 to an inflow passage (not shown in this view) in the catheter shaft. A separate arm 334 connecting the outflow flow line to the outflow passage (also not shown in this figure). The two flow lines 337 may include both inflow and outflow flow lines 333, 335 for connecting the catheter shaft 326 to the disposable heat exchange plate 338. In addition, one flow line, for example, the inflow flow line 333, may be coupled to a bag 339 of heat exchange fluid 331 to trigger a closed loop heat exchange balloon catheter system as needed.

  The heat exchange plate 338 may include a serpentine path 339 for heat exchange fluid that is pumped through the heat exchange plate by the disposable pump head 340. A heat exchange plate 338 having a serpentine path 339 and a pump head 340 is designed to be installed in a reusable master controller 341. The master controller may comprise a heat generation or heat removal device 342 such as a thermoelectric heater / cooler (TE cooler). TE coolers are particularly advantageous because they can generate or remove heat by changing the polarity of the current that operates the device. Thus, the supply of heat to the system or the removal of heat from the system can be conveniently controlled without the need for two separate serpentine devices.

  The master controller has a pump driver 343 for operating the pump head 340 to pump the heat exchange fluid 331 and circulating the fluid 331 through the heat exchanger 327 and the serpentine path of the heat exchange plate. ing. Once installed, the heat exchange plate is in communication with the TE cooler so that there is a return of heat, so that the TE cooler exchanges heat as the heat exchange fluid circulates through the serpentine path. It may serve to heat or cool the fluid. The heat exchange fluid may serve to add heat to or remove heat from the patient's body as it circulates through a heat exchanger disposed within the patient's body. In this way, the TE cooler can serve to change the blood of the patient as desired.

  The TE cooler and pump are responsive to the controller 344. The control device includes a plurality of sensors, such as a plurality of temperature sensors 348, 349, etc. that can sense temperature from the patient's ear, brain region, bladder, rectum, esophagus, or other suitable location desired by the operator installing the sensor. Input data is received via electrical connections 345, 346, 347 to electrical sensors. Further, sensor 350 may monitor the temperature of the heat exchange balloon, and other sensors (not shown) may monitor blood temperature at the catheter tip, proximal catheter end, or other desired location, as desired. Can be deployed.

  An operator may use a manual input device 351 to enter operating parameters of the control system, such as a preselected temperature for the brain. The parameters are transmitted to the controller via a connection 353 between the manual input device 351 and the controller 344.

  In practice, an operator using a manual input device provides a set of parameters to the controller 344. For example, a desired temperature for the patient's brain region and / or whole body may be designated as the preselected temperature. The data is received from, for example, sensors 348 and 349 that indicate the patient's detected temperature at the sensor location, for example, the patient's measured core temperature or brain region measured temperature. Other data inputs may include the actual temperature of the heat exchanger, the blood temperature at the tip of the catheter body, and the like.

  The controller adjusts data and selectively activates various devices of the system to execute and maintain parameters. For example, the controller may increase the amount of heat removed if the measured temperature is higher than the specified temperature, or decrease the amount of heat removed if the measured temperature is lower than the specified temperature. The TE cooler can be activated to The controller may stop pumping the heat exchange fluid if the sensed whole body or local temperature is the desired temperature.

  The controller may have an operational buffer range that defines a target temperature and also sets an upper dispersion setpoint temperature and a lower dispersion setpoint temperature. In this way, the controller can operate the heat exchanger until the target temperature is reached. Once the target temperature is reached, the controller can stop the heat exchanger operation until either the upper dispersion set point temperature is sensed or the lower dispersion set point temperature is reached. When the upper dispersion set point temperature is detected, the controller activates the heat exchanger to remove heat from the bloodstream. On the other hand, when the lower dispersion set point temperature is detected, the control device operates the heat exchanger so as to add heat to the blood flow. This control mechanism is similar to that shown in FIGS. 5 and 6 described above. Applying such a control mechanism to the system has the advantage that the operator can substantially adjust the desired temperature, which serves to reach the target temperature and keep the patient at the target temperature. At the same time, when the target temperature is reached, the control unit is usually in a buffer range to avoid turning the TE cooler on and off, or actuating or stopping the driver, which is a potentially harmful action to the electrical device. Determine.

  It will also be appreciated that, in accordance with the present invention, the controller can be designed to respond to several sensors simultaneously, or to activate and deactivate various components such as several heat exchangers. In this case, the control device, for example, heats blood that is circulated to the core later in response to the detected body core temperature below the target temperature, and simultaneously responds to the detected brain temperature that exceeds the target temperature. The second heat exchanger may be activated to cool the blood toward the area. If the detected body temperature is the target temperature, the controller switches off the heat exchanger that is in contact with the blood circulating toward the core, and at the same time, the controller cools the blood toward the brain region. It is also possible to continue operating the heat exchanger. Any of a number of control mechanisms that can be predicted by an operator and programmed into the controller are encompassed by the present invention.

  An advantage of the illustrated system is that all parts of the system that contact the patient are disposable, but substantially and relatively expensive parts of the system are reusable. Accordingly, the catheter, the sterilized heat exchange fluid passage, the sterilized heat exchange fluid itself, and the pump head are all disposable. If the heat exchange balloon ruptures and the heat exchange passage, and thus the pump head, contacts the patient's blood, there will be no cross-contamination with the patient because all of these parts are disposable. However, the pump driver, electronic control mechanism, TE cooler, and manual input device are all reusable for economy and convenience. Further, the sensor may be disposable, but the control device coupled to the sensor is reusable.

  It will be readily apparent to those skilled in the art that the system described in detail herein can be used with many substitutions, deletions, and alternatives without departing from the spirit of the invention as claimed herein. Will be understood. For example, the serpentine path can be a coil or other suitable shape, the sensor can sense a wide variety of body positions, can supply other parameters such as temperature or pressure to the controller, and the heat exchanger can It may be of any suitable type such as, but not limited to, a thermoelectric heating device that does not require circulation of heat exchange fluid. If provided with a heat exchange balloon, it may be equipped with a pump such as a screw pump, gear pump, diaphragm pump, peristaltic roller pump or other suitable means for pumping heat exchange fluid. All of these and other substitutions obvious to those skilled in the art are contemplated by the present invention.

  17A-E show one embodiment of the heat exchanger of the present invention. As shown in FIG. 17A, a heat exchange balloon catheter 360 having a finned balloon portion 362 may be placed in a blood vessel 366 that directs blood flow to at least a portion of the descending aorta 364 and the brain region. The balloon portion 362 is thin enough to promote effective heat transfer between the heat exchange fluid in the balloon and the blood flowing in close proximity to the balloon, but when inflated, the fluid passage or vessel It should be understood that the 366 may be formed from a material that is not excessively flexible enough to unintentionally occlude. To obtain a predictable balloon shape with appropriate heat exchange properties, a material such as PET that is thin and strong but relatively inflexible is certainly desirable. The catheter shaft 368 of the thermal catheter 360 provided in this embodiment is placed in the desired position with respect to the selected body region or artery 366 by conventional techniques such as guide catheters or steerable wire over the wire techniques known to those skilled in the art. Can be placed. The balloon portion 362 of the catheter 360 may support a closed loop circulation of heat transfer fluid as described herein. As the surface area increases, heat transfer provides effective heat transfer within the body region, and further, when the balloon is inflated, a continuous passage of blood without substantial rupture by forming a passage outside the balloon surface. The flow becomes possible.

  FIG. 17B shows a heat exchange balloon 360 mounted on a shaft 368, which has a longitudinal axis 370 and a plurality of heat transfer fins 369, 371 projecting radially outward from the longitudinal axis 370. 373 and 375. The heat transfer fins may be formed, for example, as a multilobe folding balloon lobe. The shaft 368 is generally round and in this embodiment has a working lumen 370 that extends through the shaft and is open at the tip of the catheter. Working lumens are, for example, thrombolytic agents, anticoagulants, neuroprotective agents, barbiturates, anti-seizure agents, oxygenated perfusates, vasodilators, vasospasm inhibitors, platelet activation inhibitors, and platelet coagulation agents. It can be used to inject drugs that can contain anti-adhesive agents. Alternatively, the working lumen can be an injection of fluoroscopic dye, a guidewire 329, or an angioplasty catheter, an embolectomy catheter, an occlusion member delivery catheter, an embolus member delivery catheter, an electrocautery device, or a microcatheter, for example. Can be used as a guide catheter for various diagnostic or therapeutic devices. The shaft outside the central lumen is divided by the web 372 into two passages, an inflow passage 374 and an outflow passage 376. The shaft has inflow orifices 377, 378, 379 that communicate the inflow passage with the interior of the balloon at the tip of the balloon. The shaft further has outflow orifices 380, 381, 382 communicating between the interior of the balloon and the outflow passage. A plug 384 is inserted in the outflow passage between the inflow orifice and the outflow orifice. Web 372 may be removed from the shaft between the plug and the inlet orifice to reduce resistance to heat exchange fluid flow in this portion of the shaft. Alternatively, in certain embodiments not shown herein, a tube having a round open lumen that provides a passage for obtaining a relatively unoccluded flow of heat exchange fluid under the balloon between the outlet passage plug and the inlet orifice. Can be joined.

  The balloon can be made, for example, of a single sheet of foldable plastic material 285 that is thin enough to allow effective heat exchange between the heat exchange fluid inside the balloon and the blood flowing outside the balloon. This material can be lightly fastened to the shaft as shown at 286 to form a balloon lobe. Further, as shown at 287 and 288, the plastic sheet itself can be lightly secured in place to form a lobe. The lobe-shaped balloon surface provides a significant surface for heat exchange while at the same time providing a continuous flow through the balloon through the space between the balloon lobes.

  In use, heat exchange fluid (not shown) may be pumped into the inflow passage 374 under moderate pressure. The heat exchange fluid may be, for example, a sterile saline solution or other biocompatible fluid with suitable heat transfer characteristics. The heat exchange fluid reaches the inlet orifices 377, 378, 379 at the tip of the balloon through the inlet passage. The fluid flows from the inflow passage into the balloon. The fluid then flows proximally through the interior of the balloon and reaches the outlet orifices 380, 381, 382 at the proximal end of the balloon. The heat exchange fluid then flows from the inside of the balloon through the outflow orifice and into the outflow passage 376 where it flows back down from the shaft and out of the body.

  As described above, the heat exchange fluid circulates through the balloon and releases heat when the heat exchange fluid is warmer than the blood flowing through the balloon and absorbs heat when the heat exchange fluid is colder than the blood.

  18A-18E illustrate another modified heat exchange catheter 390 of the present invention formed with a sleeve with an internal fluid passage 392 that provides locally limited heat transfer. The heat transfer catheter 390 can include a blood guide sleeve 394 for placement within a fluid-containing body region, which sleeve is defined by a proximal region 396 and a distal region 398 formed using an internal fluid passage 392. And the internal fluid passage 392 has at least one relatively proximal opening 395 and at least one relatively proximal opening that are each in communication with a body region containing fluid to direct fluid flow into the catheter body 394. It is partitioned by an opening 399 near the tip. A heat exchanger is disposed inside at least a portion of the sleeve to obtain locally limited heat transfer with the fluid in the internal fluid passage 392 of the blood guide sleeve. 18A-18E, the heat exchanger shown is a grooved closed loop exchanger disposed on the circumference of the internal passage 392 to circulate the heat exchange fluid, as described in detail below. is there.

  As shown in FIG. 18A, a temperature regulating catheter 390 may be placed in at least a portion of the aorta 364 and a blood vessel 399 that branches off from the aorta to direct blood to the brain region. The catheter is placed in an innominate artery, but for example, its tip may be placed in the right common carotid artery, left common carotid artery, right internal carotid artery and left internal carotid artery, among others. Thus, blood can be directed to the brain region while passing through a heat exchanger disposed within the internal fluid passage 392 of the catheter body 394. Forming a heat exchanger to cool the blood flowing through the internal passage 392 and positioning the catheter as shown in FIG. 24A can effectively achieve localized hypothermia in the brain region. The temperature regulating catheter 390 is also selected for applicable methods for regulating the temperature of other selected fluid containing body regions, for example, where the catheter is positioned to selectively direct blood to the fluid containing body region. Can be done.

  As shown in detail in FIGS. 18B-G, the catheter can also be formed with a proximal shaft 400, which has two arcuate lumens shaped adjacent to the central working lumen. And have. The two lumens include an inflow lumen 402 and an outflow conduit 403. A blood guide sleeve is attached to the proximal attachment region 404 of the proximal shaft. This sleeve has a layer 405 made of a very thin material such as a PET sheet formed in a large tube-like shape. The catheter shaft is located downstream in the tube, and the sheet is bonded around the top 406 and bottom 407 of the catheter shaft along the length of the sleeve. This creates two wing-like passages 408, 409, which are the inflow and outflow passages, respectively, on each side of the catheter over the length of the sleeve. The outer plastic sheet layers of each of these passages can be connected to each other at the top of the passage 410 to form a tube-like structure that constitutes the sleeve. Further, to form pleats 412, the two plastic sheet layers that make up each passage may be joined together at various points along the length of the sleeve or along line 411, and inner layer 405 is inflated. It should be loose so that the passages undulate.

  At a distance from the sleeve's proximal attachment region 404, there is one orifice 415 between the inflow lumen 402 and the catheter shaft inflow passage 409, and between the outflow lumen 403 and the sleeve outflow passage 408. One orifice 416 is formed in each. At the leading end of the sleeve, an inflow passage 409 and an outflow passage 408 are connected between the plastic sheets, and as a result, there will be a flow of fluid downstream of the inflow side, as described in detail below. There is a shared space 413 shared by the two passages so that it can be removed through. The catheter shaft under the sleeve may have a reduced configuration as shown in FIG. 18B so that a thin plastic sheet sleeve can be folded over the catheter shaft and have a suitably small cross-section.

  As an alternative construction, the sleeve can be formed using two tubes. Insert the catheter shaft into the larger outer tube and insert the slightly smaller inner tube into the outer tube but over the catheter shaft. The outer tube is sealed at the bottom of the catheter shaft along its length, and the inner tube is sealed at the head of the catheter shaft along its length. The inner and outer tubes are sealed together along a line facing the catheter shaft so as to form two passages therebetween. The seal facing the shaft does not extend all the way to the end, which serves to form a shared space for communication between the inflow and outflow passages.

  Yet another configuration of such a device is to fold a thin plastic large tube inwardly to create an internal passage delimited by two layers of thin plastic, the thin plastic layers being It is substantially joined at the tip of the. The space between the two plastic layers constitutes an inflow passage and an outflow passage. The catheter shaft can be placed in the internal passage and the two layers can be sealed to the catheter shaft over the length of the internal passage relative to each other and along the bottom of the catheter shaft. The two plastic layers further seal each other along the head of the internal passage from the proximal opening to a point just before the tip of the internal passage. As a result, the inflow passage 409 and the outflow passage 408 are formed, and at the same time, the shared space 413 remains at the tip of the sleeve.

  In use, heat exchange fluid (not shown) is introduced into the inflow lumen 402 of the proximal shaft 404 under pressure. The heat exchange fluid is directed downstream of the shaft to the inflow orifice 415 and at this point enters the inflow passage 409 between the two plastic sheet layers on the inflow orifice side. The fluid is then directed downstream through the inflow passage, substantially expanding the corrugated pleat of the sleeve somewhat. The fluid enters a shared space 413 at the tip of the blood guide sleeve and enters an outflow passage 408 formed between the plastic sheet layers on the outflow side of the sleeve. The fluid returns through the length of the sleeve, through the pleat passage, and back to the outflow orifice 416 formed between the outflow passage 408 and outflow lumen 403 of the catheter shaft. The fluid then exits the body down the outflow passage. In this way, the heat exchange fluid may circulate through a structure that creates heat exchange with blood that travels in close proximity to the internal passage to exchange heat with the heat exchange fluid.

  By forming the internal passageway using a thin plastic sheet, the blood guiding sleeve can be shrunk to a small cross section, for example, the internal passageway can be wrapped or folded over the reduced cross section portion of the catheter shaft . This in turn provides a low profile device for insertion into the vasculature. A corrugated structure formed of plastic sheet pleats, when expanded by a circulating heat exchange fluid, between the heat exchange fluid flowing in the catheter body and the adjacent blood or other body fluid to exchange heat in the internal passageway. Increase heat exchange surface area.

  In another embodiment shown in FIG. 19, the heat transfer catheter 420 is as a blood guiding sleeve forming an internal passage 423 having a heat exchanger such as a heat exchange balloon catheter 424 disposed within the internal passage 423. It may have a formed catheter body 422. The heat exchanger may be any suitable heat exchanger, but in the embodiment shown, the heat exchanger is a heat transfer balloon catheter, such as described in the previous section or FIG. 17B or below. 24A of the type shown in FIG. The heat exchanger must have sufficient size and shape to provide sufficient heat exchange capability and to allow the fluid flowing through the internal passage to flow properly.

  The blood guide sleeve has a proximal section 426 having a proximal opening 428. Further, the wall of the proximal section of the sleeve may form an orifice 430 that further facilitates perfusion of fluid from surrounding body parts into the internal passage.

  The sleeve further has an intermediate section 432. The wall of the intermediate section of the sleeve is generally solid so that fluid does not pass through the wall of the intermediate section and exit the internal passage. The sleeve in the intermediate section 432, in fact the wall spanning its length, may be formed of a thermally insulating material to insulate fluid in the internal passage from tissue such as blood outside the internal passage. Thus, fluid entering the internal passage from the proximal section 426 will be directed through the intermediate section 432 to the distal section 434 of the blood guide sleeve.

  The tip section 434 of the blood guide sleeve has a tip opening 436. In addition, the wall of the distal section of the blood guide sleeve may form an orifice 438 that further facilitates fluid flow out of the internal passage and into surrounding body parts such as blood vessels. The sleeve tip 436 is near the tip of the heat exchanger 440, is coextensive with the end of the heat exchanger (not shown), or is distal from the heat exchanger as shown in FIG. It may extend to the side.

  In addition, there may be a central working lumen 442 extending from the proximal end of the catheter shaft outside the patient's body to the distal end 443 of the catheter shaft. The central lumen may extend through the tip of the heat exchange balloon or even through the tip of the sleeve. The working lumen receives a guide wire or performs dye injection, clot lysis or injection through a microcatheter or working tube as described above with particular reference to the working lumen shown in FIG. It can be used to insert a microcatheter for additional procedures such as other uses of the cavity. It will be readily appreciated that any of the above uses of the working lumen can be performed before, after, or during the cooling of the blood within the blood guide sleeve. It would be an advantage of the catheter of the present invention that the working lumen could be used for any of the above purposes while at the same time cooling without impeding the cooling function of the catheter.

  In use, the heat transfer catheter is placed in a fluid containing body, eg, the arterial system, as shown in FIG. The proximal end of the blood guide sleeve may be disposed within the descending aorta 446, for example. The distal end of the catheter body is placed as desired, but in the illustrated case it is placed in the left common carotid artery 448 that supplies blood to the brain. The pressure difference between the aorta at the proximal end of the sleeve and the left common carotid artery at the distal end of the sleeve is sufficient to allow blood to flow into and out of the left common carotid artery through the sleeve It is. In the illustrated case, blood enters an internal passage of a blood guide sleeve located in the aorta through which a heat exchange balloon 424 is circulated through a heated or cooled heat exchange fluid. It flows close to heat exchange. In this way, the blood is heated or cooled. The heated or cooled blood is then guided from the tip of the internal passage and flows into the left common carotid artery. When the heat exchanger is cooling the blood, the cooled blood is directed to the left common carotid artery and the brain is immersed in the cooled blood. If this is maintained for a sufficient length of time, local cooling of the brain tissue can occur that has the advantages of the above-described conditions.

  Placing the proximal opening 423 of the blood guide sleeve downstream of the descending aorta somewhat away from the aortic arch 447 captures blood by the blood guide sleeve located entirely within the left common carotid artery and passes through the internal passageway. Rather than being guided, a longer blood tract will be obtained across the heat exchange balloon catheter to the right common carotid artery. This long passage provides a high cooling effect compared to a short passage. Also, by placing the blood guide sleeve at least partially within the aorta, for example, a larger heat exchanger, such as a large diameter than is possible when the heat exchanger of the catheter is placed in the right common carotid artery. It is possible to use a heat exchange balloon having This is because the aorta is significantly larger in diameter than the right common carotid artery.

  The distal section 434 of the blood guide sleeve can also be formed to fit relatively closely around the vessel being deployed. In this way, the pressure differential between the proximal and distal ends of the sleeve is maximized, for example, substantially all blood flowing from the aorta to the carotid artery passes through the internal passage and is heated or cooled by a heat exchanger. The The wall of the blood guide sleeve may constitute a closed shoulder that facilitates the sealing of the artery. The heat exchanger is, for example, a heat transfer balloon that holds the catheter body in an extended state, and the heat exchange balloon has fins and the like, thereby, between the fins of the heat exchange balloon and the inner wall of the internal passage. Significant blood flow to and from the balloon is possible, with most if not all blood flowing into the right common carotid artery flowing through the heat exchanger, thereby being heated or cooled.

  Another embodiment of the heat transfer catheter of the present invention is shown in FIG. The catheter 450 may be equipped with a blood guide sleeve 452 for receiving and guiding body fluids such as blood. The sleeve may be substantially funnel shaped with a tip region 454 that is significantly larger in diameter than its tip region 456. In this way, the outer surface of the blood guide sleeve can form a closed shoulder that can be pressed or supported against a suitable anatomical structure such as the interior of the artery so that most of it flows into the artery. Or substantially all of the blood is directed to the internal passage 464 of the blood guiding sleeve before entering the artery. In the illustrated embodiment, the artery into which the catheter body is inserted is the left common carotid artery, but it can be designed so that the tip of the blood guide sleeve is similarly positioned at other desired locations. Those skilled in the art will readily understand.

  The tip region is elongated with a substantially cylindrical shape and may terminate at the tip opening 458. The proximal region can also have a proximal opening 460, which can have a valve 462 for controlling its opening or closing or the flow of blood into an internal passage 464 within the catheter body.

  A heat exchanger is accommodated in the proximal end region 454. The heat exchanger shown is a series of helical fins 466 that can contain a heat transfer balloon or balloon lobe for circulating a heat transfer fluid. Alternatively, the fins can be other types of heating or cooling mechanisms such as electrical resistance heaters.

  The heat transfer catheter is equipped with a catheter shaft 468 that may include a working lumen 470, which extends outside the patient's body when the heat exchange catheter is in place, thus injecting drugs, fluoroscopic dyes, and the like. Or a guide wire 472 for heat transfer catheter placement. The shaft may have a passage (not shown) for the flow of heat transfer fluid or may further include an electrical wire (not shown) for coupling to a heat exchanger or sensor (not shown) on the catheter. .

  In use, the heat transfer catheter 450 is placed at the desired body location. In FIG. 20, the catheter is positioned so that the proximal end of blood guide sleeve 454 is in aorta 474 and its distal end 456 is in left common carotid artery 476. The blood flows in the direction of the aorta (indicated by arrow “F”) and can enter the proximal opening 460 of the catheter body if the valve 462 is open. The pressure difference between the blood in the aorta and the blood in the left large common carotid artery is sufficient to allow blood to flow into the internal passage. As blood flows upstream through the internal passage, it flows in close proximity to heat exchange with the heat exchange fins 466 and is heated or cooled. Heated or cooled blood is guided to the left common carotid artery by a blood guide sleeve, and finally the brain is placed in a heated or cooled blood bath. If this condition is maintained for a sufficient length of time, local heating or cooling of the brain can occur.

  Another embodiment of the heat transfer catheter of the present invention is shown in FIG. The catheter 490 shown in this figure includes a blood guide sleeve 492 designed to be placed in a blood vessel of a patient's body, for example, the aorta leading to the brain region 494. The blood guiding sleeve is substantially cylindrical, but may have a slightly enlarged proximal section 496 that forms the shoulder of the catheter body, the shoulder guiding the blood guiding sleeve from the coronary arch. When placed in an artery such as a branching artery, it can serve as a closed shoulder 498.

  The blood guide sleeve has a tubular shape and defines an internal passage 500 that extends from a proximal section 496 starting at the proximal opening 502 to a distal end terminating at the distal opening 504. A heat exchanger, such as a finned balloon heat exchange catheter 506 as described and shown in FIGS. 17B and 24A, may be installed within the catheter body and fully contained within the sleeve internal passageway 500. The fins 508 increase the heat transfer surface with respect to the cylindrical heat exchange balloon and also allow flow of blood flow from the proximal opening, beyond the fins of the heat exchange balloon and through the fins and out of the tip of the internal passage. An inter-fin passage is formed. The catheter shaft 509 may be equipped as described in connection with the other embodiments described above.

  FIGS. 21B-D illustrate the operation of a control system that regulates the opening and closing of the valve assembly 460, which includes a sleeve 492, such as a proximal opening 502, to control the flow of blood in the internal passage 500. You may form along any part of these. For example, two leaflet valves 510 at the proximal opening of sleeve 492 may be placed around the catheter shaft. Valve 510 may have at least one closed position as shown in FIG. 21B and at least one open position as shown in FIG. 21C. Other valves, such as a check valve, may be selected for the catheter body, and the valve may open and close in variable degrees to adjust the amount of fluid that passes through the sleeve at a selected time.

  The valve 510 may open and close synchronously according to the patient's heart rate, as shown in the graph of FIG. 21D. Since aortic blood flow (L / min) is pulsatile and fluctuates at different time intervals during the cardiac cycle, the valve can be selectively opened when a relatively large amount of blood is released from the heart. At the same time, when the blood flow is slow, the valve can be selectively closed to maintain the blood in the internal passageway 500. Alternatively, to maximize the heating or cooling of all blood flowing from the catheter body into the distal artery, control the valve so that the blood flows more slowly through the internal passageway and slowly over the heat exchanger It can be made to flow.

  As described above, the catheter control device can simultaneously monitor body conditions or sensed stimuli such as heart rate, temperature and pressure at various locations within the device or within the patient's body. When valve 510 is in the closed state (FIG. 21B), blood or fluid is retained in internal passage 500 and is effectively cooled by heat exchanger 506 disposed therein. The valve in the closed position may prevent or minimize the backflow of cooled fluid from the brain. After the blood has cooled, when the heart begins to pump blood further toward the heat transfer catheter, the valve takes the open position (FIG. 21C) and cools the chilled blood trapped by the relatively warm incoming blood. Can operate to extrude from the area. If blood pressure or surging from the heart subsequently decreases, valve 510 closes again, and this cooling and pumping cycle continues until the desired local hypothermia level in the brain is achieved. FIG. 21D is a graph of the cycle just described.

  Although many embodiments of the present invention described so far have been shown as cooling or heating devices, it should be understood that any combination of these variations may constitute a series or network of temperature control devices. For example, as shown in FIG. 22, the heat exchange catheter 520 includes a heat transfer balloon 524 having a plurality of collapsible cooling fins 522 disposed in the aorta 526 region. Suitable finned heat transfer balloons have already been described. The heat exchange catheter may be equipped with a catheter shaft 528. The heat exchange catheter may have a heating element 530 formed at a different location from the cooling balloon 524 along the catheter shaft. The shaft 528 includes a pair of longitudinal passages (not shown) for circulating a hot heat transfer medium to the heating body and an additional pair of passages (not shown) for circulating a cold heat transfer medium to the cooling balloon 522. Not shown). Alternatively, the heating fins 530 may comprise a resistance heater or other heating element known in the art. In the case of a resistance heating element, current flows to the heating element through a wire (not shown) wound around the shaft.

  The cooling balloon 522 can include an insulating bottom surface 534. Thus, blood flowing in a particular direction, such as toward the brain, can be preferentially cooled relative to blood flowing in other areas of the patient's body, such as further down the body. In the embodiment shown in FIG. 22, the heat transfer area has a curved cooling balloon, which is insulated along the inner diameter of the curvature and is heat conductive along the outer diameter of the curvature. is there. A cooling balloon may be placed in the aortic arch. Blood is pumped into the aorta (indicated by arrow F) by the heart and a portion flows past the top surface 523 of the balloon in close proximity to the cooling balloon 522 for heat exchange. This blood is cooled and then the cooled blood naturally flows to the brain area. Blood flowing through the internal insulating radius of curvature 525 is not cooled, so normal temperature blood flows down the body through the aorta. Note that in the illustrated example, cold blood flows through all arteries extending from the aortic arch to the brain region without having to be cannulated into each of these arteries. In such a configuration, it is not necessary to equip the heat transfer catheter with a blood guiding sleeve. The reason is that induction cooling can be obtained that guides cold blood to a specific artery without using a catheter.

  As described above, the heating and cooling mechanism may be formed at various locations along the shaft 528 of the heat transfer catheter 524. Alternatively, multiple heating and cooling catheters may be used in combination or in cooperation. As previously mentioned, a shared catheter controller can monitor and control multiple devices individually or collectively and can respond to one or more sensors (not shown), such as pressure sensors or temperature sensors. .

  Another aspect of the present invention is shown in FIG. 23, in which heated or cooled blood can be directed through a relatively small blood vessel to a specific location such as a tumor or organ such as the heart. A heat transfer catheter 550 having a blood guiding sleeve 522 is provided and has a proximal opening 554 and a distal section 552. Arranged in the blood guiding sleeve is a heat exchanger 558, which may be, for example, a finned heat transfer balloon as described above. The heat transfer catheter has a catheter shaft 560 that extends from at least the interior of the blood guiding sleeve toward the tip 562. The distal section of the sleeve is sealed around the catheter shaft 564. The catheter shaft 560 has a perfusion lumen 566 extending between a blood inflow orifice 568, 570 formed at one location within the blood guide sleeve and the tip 562 of the shaft. The blood inlet orifice provides fluid communication between the perfusion lumen and the interior 572 of the blood guide sleeve.

  In use, the heat transfer catheter 560 is placed within the patient's interstitial structure, eg, the aorta 574, and positioned such that the distal end 562 of the catheter shaft 560 is at a desired location, eg, within the coronary artery ostium. Due to the pressure difference between the blood in the aorta at the proximal end of the blood guiding sleeve 552 and the distal end 566 of the catheter shaft, the blood is brought in close proximity to the heat exchanger to be heated or cooled from the proximal opening 554 of the sleeve. Into the blood inlet orifice through the internal passage and out of the distal end of the central lumen through the central lumen 578 of the catheter shaft. In this way, a heated or cooled blood flow is directed towards a specific organ or tissue, such as a heart or a tumor, and such organ or tissue is immersed in a heated or cooled blood bath. . Treating a sufficient blood supply of an organ or tissue in this manner for a sufficient amount of time will result in local heating or cooling of the organ or tissue.

  The central lumen may extend from the distal end 578 to a proximal opening outside the body. In this way, the central lumen can function as a working lumen for all the applications described above, including angioplasty and acting as a guide catheter for angioplasty. The central or working lumen may be sized to function as a guide catheter and to allow simultaneous insertion of an angioplasty catheter and cold blood perfusion through the central or working lumen.

  An alternative structure for the heat exchange balloon shown in FIG. 17 is shown in FIG. 24A, in which the heat exchange region is a series of three foldable balloon lobes 902 arranged around a central foldable lumen 908, 904 and 906 are used. A proximal shaft 910 is formed having two passages, an inflow passage 912 and an outflow passage 914. The interior of the shaft is divided into two lumens by webs 916, 917, but these lumens do not occupy equal parts within the shaft. For reasons explained below, the inflow passage occupies about 1/3 of the inner circumference and the outflow passage occupies about 2/3 of the inner circumference.

  In the heat exchange region of the catheter, a transition 915 is formed between the shaft 910 and the tube 911 that forms the central folding lumen 908. The outflow passage is closed and the tube 911 is fixed on the shaft 910 with a transition 915, for example by gluing, and the shaft terminates in a tube (not shown). In this way, the inflow passage of this portion of the catheter occupies the entire circumference of the shaft, as shown in FIG. 24C. At the tip of the balloon, inflow orifices 918, 920, 922 are formed between the inflow passage and the three folded balloons. Outlet orifices 924, 926, 928 are formed at the proximal end of the heat exchange region between the interior of each balloon and the outflow passage of the shaft. As shown in FIG. 30D, the structure of the outflow passage is designed to allow internal communication of each of the three balloons.

  Heat exchange fluid (not shown) travels down the inflow passage in shaft 912, further down lumen 908 to the tip of the heat exchange region, and exits the lumen through inflow orifices 918, 919, 920. It is understood that balloon lobes 919, 921, 923 enter the inner lumen, return from the three balloons, re-enter the shaft through outflow orifices 924, 926, 928 and then down outflow passage 914 toward the proximal end of the catheter. Like. Thus, the heat exchange fluid circulates through the balloon, adds heat to the blood flowing in close proximity to the balloon when the heat exchange fluid is warmer than the blood, and when the heat exchange fluid is colder than the blood. Heat can be removed from the blood. The material forming the balloon is made of a material that enables sufficient heat exchange between the heat exchange fluid inside the balloon and a body fluid such as blood flowing in close proximity to the surface of the balloon. One such suitable material is a very thin plastic material that is strong enough to withstand the pressures required for proper flow of heat exchange fluid.

  The same type of heat exchange balloon as described here can be used in conjunction with FIG. 17 to apply heat to the blood flow depending on the relative temperature between the heat exchange fluid and the blood flowing in close proximity to the balloon to exchange heat. It will also be readily appreciated that heat can be removed from the bloodstream. That is, by simply controlling the temperature of the heat exchange flow within the device, the same device can be used alternately at the same location to heat or remove heat.

  The heat exchange device can also be supplied as a kit comprising a heat exchange device and a set of instructions for use of the heat exchange device. The heat exchange device may include, for example, a heat exchange catheter as described in this application. The instructions for use generally teach the user how to insert the heat exchange device into the body fluid containing region and how to set the temperature of the heat exchange device that changes the temperature of the body fluid. The instructions for use may teach the user how to heat or cool the body fluid to achieve any of the objectives described in this application.

  Although all aspects of the invention have been described with reference to the above applications, the above description of various embodiments and methods should not be construed in a limiting sense. The foregoing has been presented for purposes of illustration and description. It should be understood that all aspects of the invention are not limited to the specific depictions, shapes or relative proportions described herein which depend on various conditions and variables. This description is not intended to be exhaustive, that is, to limit the invention to the precise form disclosed herein. Various changes and insubstantial changes in form and detail of particular embodiments of the disclosed invention, as well as other variations of the invention, will be apparent to those skilled in the art upon reference to the disclosure of the invention. Accordingly, the appended claims are intended to cover all modifications or variations of the described embodiments as falling within the true spirit and scope of this invention.

Claims (35)

A catheter device that can be inserted into the anatomy of a mammalian patient, through which fluid can flow to the target area of the patient, and the catheter apparatus can adjust the temperature of the target area. Functioning to perform in-situ heat exchange with bodily fluids to change, the catheter device
An elongate flexible catheter with a proximal end and a distal end, and the total length of the flexible catheter is defined as the distance between the proximal end and the distal end;
At least one fluid lumen through which the heat exchange fluid can circulate;
A heat exchanger disposed at a first position on the catheter; and the heat exchanger is heat circulated through the body fluid and the body fluid flowing in close proximity to the heat exchanger to exchange heat. Functioning to exchange heat with an exchange fluid, and wherein the first position extends less than the overall length of the catheter;
A body fluid guiding sleeve formed around a segment of the catheter including a first position where at least a portion of the heat exchanger is disposed, and the body fluid guiding sleeve is disposed between the body fluid guiding sleeve and the catheter. Forming a space through which the body fluid inducing sleeve is disposed, the body fluid inflow sleeve disposed on the proximal end side with respect to the heat exchanger, and the body fluid flow disposed on the distal end side with respect to at least a part of the heat exchanger. And the body fluid enters the flow space through the body fluid inlet, flows in the flow space in proximity to at least a portion of the heat exchanger, and then the body fluid Exiting the outlet and leading to a passage in fluid communication with the target area of the patient's body;
A catheter device. 2. The catheter device of claim 1 for adjusting the temperature of a target area of a patient's body, wherein body fluid flows to the target area through a first anatomical conduit having a first diameter. The anatomical conduit communicates with a second anatomical conduit having a second diameter larger than the first diameter so as to allow connection and fluid flow, and the body fluid guiding sleeve has a distal end portion and a proximal end portion. The distal end portion is disposed with the bodily fluid outlet, the proximal end portion is disposed with the bodily fluid inlet, and the distal end portion is advanced through the first anatomical conduit and simultaneously with the proximal end. The end portion is sized to remain disposed within the second anatomical conduit, and bodily fluid from the second anatomical conduit enters the flow space through the bodily fluid inlet, and The flow spectrum is close to the heat exchanger for heat exchange. Flows through the scan, then exits from the body fluid outlet, enters the first anatomical conduit and reach the target area of the patient's body, the catheter device. The catheter device according to claim 2, wherein a diameter of a cross section of the distal end portion of the body fluid guiding sleeve is smaller than a diameter of a cross section of the proximal end portion of the body fluid guiding sleeve. The tip portion has a shoulder formed in the tip portion, and the shoulder is sized and shaped to form a snug seal within the anatomical conduit, thereby providing the second anatomical conduit. The catheter device of claim 2, wherein substantially all of the fluid flow from the fluid to the first anatomical conduit is allowed to flow through the fluid guidance sleeve. The heat exchanger is
The catheter device according to claim 1, wherein the heat exchange fluid has at least one balloon circulated therein, and the heat exchange fin comprises a plurality of lobes. The catheter device of claim 1, wherein the at least one heat exchange fin comprises at least one outwardly extending longitudinal fin. The catheter device of claim 1, wherein the at least one heat exchange fin comprises at least one outwardly extending annular fin. The catheter device of claim 1, wherein the at least one heat exchange fin comprises at least one outwardly extending helical fin. The catheter device of claim 1, wherein the at least one heat exchange fin comprises a plurality of outwardly extending protrusions. The catheter further includes an insertion portion to be inserted into a patient's body and a working lumen, the insertion portion extends from the distal end to a point shorter than the proximal end, and the working lumen covers at least a part of the insertion portion. The catheter device of claim 1 extending therethrough. 11. A system comprising a catheter device according to claim 10, further combined with a guidewire sized to pass through the working lumen. 11. A system comprising a catheter device according to claim 10, further combined with a device for injecting a drug into the working lumen. The infusion device comprises:
Thrombolytic agents,
Anticoagulant,
Neuroprotective agent,
Barbitur,
Anti-seizure agent,
Oxygenated perfusate,
Vasodilator,
Anti-vasospasm,
13. The system of claim 12, containing a drug selected from the group of drugs consisting of a platelet activation inhibitor and a platelet adhesion inhibitor. The system comprising a catheter device according to claim 10 further combined with a diagnostic probe capable of passing through the working lumen. The diagnostic probe is:
Angiographic catheter,
Temperature sensor,
Pressure sensor,
Blood gas sensor and enzyme sensor
The system of claim 14, wherein the system is selected from the group consisting of: An apparatus for injecting a contrast medium for X-ray imaging into the working lumen, and an imaging apparatus for imaging the contrast medium for X-ray imaging injected into the working lumen;
11. A system comprising a catheter device according to claim 10 further combined with. 11. A system comprising a catheter device according to claim 10 further combined with a treatment device capable of passing through the working lumen. The therapeutic device comprises:
Angioplasty catheter,
Embolectomy catheter,
Occlusion member delivery catheter,
Embolic member delivery catheter,
18. A system according to claim 17 selected from the group of therapeutic devices consisting of electroacupuncture devices and microcatheters. The body fluid inlet is provided with a valve, and the valve is operable between an opened state and a closed state, and in the opened state, a body fluid flow passes through the body fluid inlet and enters the body fluid guiding sleeve. The catheter device according to claim 1, wherein the catheter device prevents the body fluid flow from entering the body fluid inlet and out of the body fluid guiding sleeve in the closed state. The catheter has a distal shaft portion, and the distal shaft portion extends from the inside of the body fluid guiding sleeve at a distal end side with respect to the body fluid guiding sleeve, and the distal shaft portion includes a central lumen passing through the inside, The catheter device according to claim 1, wherein a cavity communicates with the flow space at a first position so that fluid can flow back and forth, communicates with the passage, and communicates with the target region at a second position so that fluid can flow back and forth. 21. The catheter device according to claim 20, wherein the body fluid guiding sleeve is sealed around the tip shaft on the tip side of the first position. A catheter device disposed in a fluid-containing part of a mammalian patient's body to perform in situ heat exchange, the catheter device comprising:
An elongate flexible catheter with a proximal end and a distal end, and the total length of the flexible catheter is defined as the distance between the proximal end and the distal end;
The flexible catheter includes an insertion portion to be inserted into a patient, the insertion portion extending from the distal end to a point shorter than the proximal end;
A heat exchanger disposed in a first position on the catheter; and the heat exchanger circulates through the body fluid and the body fluid in close proximity to exchange heat with the heat exchanger. Functioning to exchange heat with the fluid, and the first position extends less than the entire length of the catheter, the heat exchanger is curved and has an outer surface along the outer diameter of its curvature. And having an inner surface along an inner diameter of the curvature, the outer surface and the inner surface having substantially different heat transmission rates;
A catheter device. 23. The catheter device of claim 22, wherein the upper surface has a substantially higher heat transmission rate than the lower surface. 24. The device according to claim 23, wherein the blood flowing into the head is sized and shaped to be placed along the curvature of the aorta of a human patient so that blood passes through the upper surface in close proximity to conduct heat. Catheter device. A system controllably acting on a patient temperature, said system comprising:
A catheter device having an elongated flexible catheter with a proximal end and a distal end, and a heat exchanger, and the heat exchanger has the same heat as body fluid in close proximity to exchange heat with the heat exchanger. Functioning to exchange heat with the heat exchange fluid circulating through the exchanger;
A plurality of sensors for detecting data from a patient, and the data from at least one of the sensors includes body temperature;
A controller that is responsive to data from at least one of the sensors and receives signals from the sensor to control and operate the catheter device to achieve and maintain a target body temperature;
With system. 26. The system of claim 25, further comprising a heat exchange unit, wherein the heat exchange unit functions to exchange heat with the heat exchange fluid. 27. The system of claim 26, wherein the heat exchange unit comprises a solid state thermoelectric cooler. 27. The system of claim 26, wherein the target parameter is temperature, the sensor is a temperature sensor, and the controller can function to operate the heat exchange unit. 26. The system of claim 25, further comprising a plurality of catheter devices, wherein the controller is operable to control each of the catheter devices. 30. The system of claim 29, wherein at least one catheter device provides heat to the bodily fluid at a first location and at least one catheter device removes heat from the bodily fluid at a second location. A system controllably acting on a patient temperature, said system comprising:
A plurality of catheter devices each having an elongate flexible catheter having a proximal end and a distal end; and a heat exchanger disposed at a first position on the catheter; Defined as the distance between the distal end and the distal end, the flexible catheter has an insertion portion that is inserted into a patient's body, the insertion portion extending from the distal end to a point shorter than the proximal end, and the heat exchanger comprises: A plurality of heat exchange fins extending from a surface of the heat exchanger, the heat exchange fins having an increased surface area to enhance heat exchange, and the heat exchanger exchanges heat with the heat exchanger. Functioning to exchange heat between the bodily fluid in close proximity and the heat exchange fluid circulating through the heat exchanger, and the first position is greater than the total length of the catheter. Extending briefly,
A plurality of sensors each sensing data from the patient and producing a signal in response to the data;
A manual input device that allows the operator to identify the target parameters;
A controller that receives a signal from the sensor and the target parameter, is responsive to the signal, and controls the operation of each of the catheter devices in relation to the target parameter;
With system. 32. The system of claim 31, further comprising a heat exchange unit, wherein the heat exchange unit functions to exchange heat with the heat exchange fluid. The system of claim 32, wherein the heat exchange unit comprises a solid state thermoelectric cooler. The system of claim 32, wherein the target parameter is temperature, the sensor comprises a temperature sensor, and the controller can function to operate the heat exchange unit. 32. The system of claim 31, wherein at least one catheter device provides heat to the bodily fluid at a first location and at least one catheter device deprives the bodily fluid at a second location.

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